NATIONAL GUIDELINES ON MANAGEMENT OF TUBERCULOSIS … · iv Acknowledg ement The Division of...

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NATIONAL GUIDELINES ON MANAGEMENT OF TUBERCULOSIS IN CHILDREN Ministry of Health DIVISION OF LEPROSY, TUBERCULOSIS AND LUNG DISEASE SECOND EDITION AUGUST, 2013 © 2013 Division of Leprosy, Tuberculosis and Lung Disease

Transcript of NATIONAL GUIDELINES ON MANAGEMENT OF TUBERCULOSIS … · iv Acknowledg ement The Division of...

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NATIONAL GUIDELINES ON MANAGEMENT OF

TUBERCULOSIS IN CHILDREN

Ministry of Health

DIVISION OF LEPROSY, TUBERCULOSIS AND LUNG DISEASE

SECOND EDITION AUGUST, 2013

© 2013 Division of Leprosy, Tuberculosis and Lung Disease

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Contents

Foreword ....................................................................................................................................................... iii

Acknowledgement ........................................................................................................................................ iv

List of Abbreviations ..................................................................................................................................... v

Chapter 1: Introduction and Definitions ......................................................................................................... 1

1.1 Introduction ......................................................................................................................................... 1

1.2 Definitions ........................................................................................................................................... 2

1.3 Rationale for Pediatric TB guideline ................................................................................................... 3

Chapter 2: Diagnosis of Tuberculosis in Children......................................................................................... 4

2.1 History ................................................................................................................................................. 4

2.2 P h ys i c a l examination ....................................................................................................................... 5

2.3 Investigations ....................................................................................................................................... 6

Chapter 3: Treatment of Tuberculosis .......................................................................................................... 16

4.1 Classification of TB in Children ........................................................................................................ 16

4.2 Recommended Treatment Regimens ................................................................................................. 17

4.3 Additional Management Decisions .................................................................................................... 19

4.4 Follow-up of a Child on anti-TB Therapy ......................................................................................... 20

4.5 Poor Response to Treatment .............................................................................................................. 21

4.6 Treatment Interruptions ..................................................................................................................... 22

4.7 Side effects of anti TB drugs in children .......................................................................................... 22

Chapter 4: TB and HIV Co-infection ........................................................................................................... 23

4.1 Diagnosis ........................................................................................................................................... 23

4.2 Treatment ........................................................................................................................................... 24

4.3 Prevention .......................................................................................................................................... 24

4.4 Differential Diagnosis in HIV infected Child with Chronic Respiratory Symptoms ......................... 24

4.5 Antiretroviral Therapy in HIV Infected Children with Tuberculosis ................................................. 25

4.5 Cotrimoxazole Preventive Therapy (CPT) ........................................................................................ 30

4.6 IPT in Children .................................................................................................................................. 31

Chapter 5: TB in special circumstances ..................................................................................................... 32

5.1 TB Meningitis (TBM) ....................................................................................................................... 32

5.2 Management of a Newborn born to a Mother with PTB ................................................................... 32

5.3 Drug Resistant TB ............................................................................................................................. 33

Chapter 6: TB Prevention ............................................................................................................................. 35

6.1 Screening for Child Contacts of Known TB Cases ........................................................................... 35

6.2 Management of child exposed to PTB ............................................................................................... 37

6.3 Tracing of TB Source ........................................................................................................................ 38

6.4 BCG Vaccination in Children............................................................................................................ 38

6.5 TB Infection Control.......................................................................................................................... 39

Chapter 7: Roles and Responsibility ............................................................................................................ 41

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7.1 Level 1: (family, patient, CHW, CHEW, community) ...................................................................... 41

7.2 Level 2 and 3: Dispensary and Health Centre .................................................................................. 41

7.3 Level 4, 5 and 6: District, Provincial and Referral Hospitals ............................................................ 41

7.4 Follow-up .......................................................................................................................................... 42

7.5 Health education ................................................................................................................................ 42

7.6 Case recording and reporting for childhood TB ................................................................................ 43

Chapter 8: Child nutrition and TB ............................................................................................................... 44

Annex 1: Tuberculin Skin Test (Mantoux test) ............................................................................................ 47

Administration ......................................................................................................................................... 47

Reading ................................................................................................................................................... 48

Interpretation ........................................................................................................................................... 49

Annex 2: Sputum Collection ........................................................................................................................ 50

Procedures for obtaining clinical samples for smear microscopy ............................................................ 50

Expectoration ...................................................................................................................................... 50

Gastric aspiration ................................................................................................................................ 51

Sputum Induction ................................................................................................................................ 53

Annex 3: Seven Steps for Patient Management to prevent transmission of TB in Community and health

care settings .................................................................................................................................................. 55

Annex 4: Dosages for Paediatric TB treatment using dispersible FDC tablets of RHZ, RH and single

Ethambutol tablets for NEW CASES........................................................................................................... 56

Table A1: Child between 5 and 22 kg ..................................................................................................... 56

Table A2: Child between 23 and 30 kg ................................................................................................... 56

Annex 5: Dosages for Paediatric TB treatment using dispersible FDC tablets of RHZ, RH and single

Ethambutol tablets for RETREATMENT CASES ....................................................................................... 57

Table B1: Child between 5 and 22 kg ..................................................................................................... 57

Table B2: Child between 23 and 30 kg ................................................................................................... 57

Annex 6: Child Tuberculosis Monitoring Card ............................................................................................. 58

Annex 7: Second-line anti-TB drugs for treatment of MDR*-TB in children .............................................. 61

Table C: Second-line anti-TB drugs for treatment of MDR-TB in children ............................................ 61

Annex 8: Taking Anthropometric Measurements ........................................................................................ 62

Annex 9: Growth monitoring charts ............................................................................................................. 65

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Foreword

Treatment of tuberculosis has over the years focused more on adults leaving children

unattended appropriately as medical practitioners considered children of little epidemiologic

significance. Available data indicate that more than 11% of TB cases notified in Kenya are

children below 15 years. This is thought to be an under estimate considering the challenges faced

in diagnosing TB in children.

With the emergence of Drug resistant TB, children are victims of contacts and poor case

control of adult TB cases. This pool of cases will defeat the ultimate aim of eliminating TB.

Kenya has pioneered interest in TB control amongst children by defining the epidemiologic

parameters for children in age groups 0–4, 5–9 and 10 – 14 years.

Since children are born without TB and they are an important segment of the society for they

signify the future, these guidelines seek to provide guidance to the management of TB in

children. It seeks to demystify TB diagnosis in children especially with the coming of new

diagnostic methods expected to revolutionalize TB diagnosis and management.

The guideline is specifically designed for general health care workers’ readership and is therefore

expected to stimulate interest in pediatric TB treatment and how to protect the children from

getting infected. This guideline will also act as a reference material for medical students,

researchers and the community.

Dr. S. K. Sharif, MBS, MBChB, M. Med. DLSHTM, MSc.

Director of Public Health

Ministry of Health

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Acknowledgement

The Division of Leprosy, Tuberculosis and Lung Disease is indebted to support received from

the Ministry of Health l e a d e r s h i p a n d health care workers in the implementation of TB

control activities in the country.

The Division specifically, acknowledges the support received from the following officers who

worked tirelessly and sometimes worked late into the night in the revision of the first edition

of this guideline.

Dr. Joel Kangangi WHO

Dr. Agnes Langat CDC

Dr. Maurice Maina USAID-Kenya

Dr. Herman Weyenga DLTLD

Dr. Bernard Langat DLTLD

Dr. Kamene Kimenye DLTLD

Dr. Richard Muthoka DLTLD

Dr. Hajara El Busaidy RTLC Coast

Dr. Immaculate Kathure RTLC Nairobi

Dr. Shobha Vakil NASCOP

Prof. Elizabeth Obimbo UON

Dr. Diana Marandu UON

Dr. Evans Amukoye KEMRI

Dr. Francis Ogaro MTRH

Dr. Lorraine Mugambi CHS

Dr. Maureen Syowai ICAP

Dr. Teresa Alwar ICAP

Dr. Kihara Ruth CHS

Ms. Christine Awuor NASCOP

The division extends its appreciation to CDC fo r providing the funds for pr int ing o f this

guideline.

Dr. Joseph Sitienei, OGW, MPH, MBA, MBChB, Dip

Head, DLTLD

Ministry of Health

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List of Abbreviations

AFB Acid Fast Bacilli

ART Antiretroviral therapy

BCG Bacille Calmette Guerin

CXR Chest X-ray

DLTLD Division of Leprosy Tuberculosis and Lung Disease

DOT Directly observed therapy

DST Drug Susceptibility Testing

HIV Human Immunodeficiency Virus

IPT Isoniazid Preventive Therapy

MDR –TB Multi-drug resistant

NNRTI NonNucleoside Reverse Transcriptase Inhibitor

NRTI Nucleoside Reverse Transcriptase Inhibitor

PPD Purified protein derivative

PTB Pulmonary Tuberculosis

RTLC Regional Tuberculosis and Leprosy Coordinator

TB Tuberculosis

TST Tuberculin Skin Test

WHO World Health Organization

XDR-TB Extensively Resistant Tuberculosis

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Chapter 1: Introduction and Definitions

1.1 Introduction

It is estimated that one third of the world’s population is infected with Mycobacterium

tuberculosis (the bacterium that causes tuberculosis (TB). Each year, about 9 million people

develop TB, of whom about 2 million die. Of the 9 million annual TB cases, about 15% occur in

children (under 15 years of age). Kenya is among the 22 TB high TB burden countries in the

world and is among the top 5 from sub Saharan Africa. 75% of these childhood cases occur

annually in these 22 high-burden countries that together account for 80% of the world’s

estimated incident cases.

In 2012 Kenya reported a total of 99,159 cases of all forms of TB (case notification rate

of 241/100,000). Paediatric age group of less than 15 years constituted 9.3% of all cases

notified which is a significant proportion requiring special attention. In the last 5 years, Kenya has

reported annual decline in the number of reported TB cases at a rate of 1% possibly due to

effective control interventions coupled with the declining HIV prevalence in the population.

Infection with M. tuberculosis usually results from inhalation of infected droplets produced by a

patient who has pulmonary TB. The source of infection for most children is an infectious adult

in their close environment (usually the household). This exposure leads to the development of a

primary parenchymal lesion (Ghon focus) in the lung with spread to the regional lymph nodes.

The immune response (delayed hypersensitivity and cellular immunity) develops about 4–6

weeks after t h e p r i ma r y infection. In most cases , t h e immune response s t o p s t h e

multiplication o f M . Tuberculosis b a c i l l i at t h i s s t a g e . However, a few dormant bacilli

may persist. A positive tuberculin skin test (TST) where available would be the only evidence of

infection.

In some cases, the immune response is not strong enough to contain the infection and

disease occurs within a few months. Risk of progression to disease and development of

disseminated TB is increased in the very young (0-4 years), immunocompromised and

malnourished children. In the vast majority o f ch i ld ren who develop disease, they usually do

so within 2 years following exposure and infection. Children can present with TB at any age, but

the most common age is between 1 and 4 years. HIV infected children have a lifelong risk of

developing TB.

TB in young children and in the HIV infected is often disseminated and

rapidly progressive

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1.2 Definitions

Infection with Mycobacterium tuberculosis usually results from inhalation of infected

droplets produced by someone who has PTB and who is coughing. The most infectious index

cases are those with sputum smear-positive disease. The closer the contact is to the source case,

the greater the exposure and the greater the risk of getting infected with tuberculosis.

TB infection is when a person carries the Mycobacterium tuberculosis bacteria inside the body.

Many people have TB infection and are well. A positive TST indicates infection - but a

negative TST does not exclude the possibility of infection.

TB disease occurs in someone with TB infection when the bacteria inside the body start to

multiply and become numerous enough to damage one or more organs of the body. This damage

causes clinical symptoms and signs and is referred to as “tuberculosis” or active disease.

Index Case: Usually an adult with smear positive pulmonary TB.

Close contact is defined as living in the same household as, or in frequent contact with

(e.g. child minder, school staff), an index case with PTB.

Children refers to the 0 to 14 year age group

Infant is a child of less than 1 year of age (0-12 month age group)

Pulmonary TB sputum positive

A child is defined as smear positive if any of the following is true:

1. AFB are detected via microscopy on either a sputum or gastric lavage sample.

2. MTB is isolated by culture on either a sputum or gastric lavage sample.

3. MTB is detected by MTB/RIF Gene Xpert on either a sputum or gastric lavage sample.

Pulmonary TB sputum negative.

A child that has the signs and symptoms for pulmonary TB, but does not meet the above criteria for

pulmonary TB sputum positive is classified as smear negative TB. This also includes children in

whom sputum smear not done or not available.

Extra pulmonary TB

Any TB occurring outside the lungs is classified as EPTB.

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Drug Resistant TB

This is a laboratory diagnosis. Drug resistant TB should be suspected if:

1. Child has contact with a known case of DRTB

2. Child has contact with an adult who has suspected DRTB as follows:

The adult remains sputum smear positive after 2 months of treatment,

An adult who has a history of previously treated TB,

An adult with a history of treatment interruption.

3. Child is not responding to the anti- TB treatment regimen

4. Child has a recurrence of TB after successful TB treatment

1.3 Rationale for Pediatric TB guideline

The TB control program has in the past paid less attention on pediatric TB mainly due to the fact

that children with TB rarely transmit the infection. However children contribute a significant

proportion of the disease burden and suffer severe tuberculosis related morbidity and mortality,

particularly in the endemic areas. The diagnosis of TB in children is particularly difficulty, more

so in resource constrained settings like in Kenya with poor laboratory and X-ray services and high

TB/HIV co infection rates. Hence there is need for pediatric TB management guidelines that will

enhance early and accurate case identification and treatment as well as contact screening and

management.

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Chapter 2: Diagnosis of Tuberculosis in Children

The diagnosis of TB in children relies on history physical examination as well as any relevant

investigations e.g. TST, CXR and sputum smear microscopy. Even though microbiological

diagnosis is not always feasible, all efforts should be made to do sputum microscopy where

possible in children with suspected pulmonary tuberculosis. A trial treatment with anti- TB

drugs is not recommended as a method of diagnosing TB in children.

2.1 History

The key elements of History are:

a) H i s t o r y o f contact with an adolescent or adult with proven or suspected TB.

Close contact is defined as living in the same household as or in frequent contact with smear

positive PTB ind ex case.

If no index case is identified, always ask about anyone in the household / dormitory / classroom

/ school transport with chronic cough- if present request assessment of that person for possible TB.

Most children will develop TB within one year of exposure

b) Symptoms suggestive of TB

The commonest symptoms associated with TB include the following:

Progressive and non-remitting cough for more than 2 weeks

Fever for more than 2 weeks

Lethargy / reduced playfulness / less active for more than 2 weeks

Weight loss, no weight gain or poor weight gain (failure to thrive)

The diagnosis of TB in children relies on a careful history and thorough

physical examination

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2.2 Physical examination

Respiratory system

During the physical examination, the following features may be found in the respiratory system:

Child may have increased respiratory rate

Child may have signs of respiratory distress

Percussion may be normal. In pleural effusion have a stony dull percussion note

Auscultation is frequently normal. May have abnormal sounds (e.g. wheezing, crackles,

bronchial breathing)

In some cases, there may be atypical clinical presentations of PTB. In this case the child will

present with features of:

Acute severe pneumonia

Presents with fast breathing and chest in-drawing

Occurs especially in infants and HIV-infected children

Suspect PTB if response to antibiotic therapy is poor. If HIV infected also suspect other HIV-

related lung disease e.g. PCP.

Wheeze

Asymmetrical and persistent wheeze can be caused by airway compression due to enlarged

tuberculous hilar lymph nodes.

Suspect PTB when wheeze is asymmetrical, persistent and non responsive to bronchodilator

therapy.

PTB can also present acutely as bronchopneumonia in children with

tachypnoea, respiratory distress and crackles.

A normal respiratory clinical finding does not rule out PTB.

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Other systems

TB can affect any part of the body apart from the hair, nails and teeth. Apart from the general

physical features suggestive of TB, a child may also present with features that are specific to the

affected system e.g. in TB meningitis a child may have features of raised intracranial pressure or

neurological deficit.

This further increases the need to have a thorough physical examination.

2.3 Investigations

After history and physical examination, if investigations are available in the facility or

nearby, attempt should be made to investigate every child suspected to have TB as follows:

a) Tuberculin Skin Test (Mantoux test)

A positive Mantoux test is evidence that one is infected with M. Tuberculosis, but doesn’t

necessarily indicate disease. Correct technique o f administering, reading and in terpre ta t io n

o f Mantoux text is very important. (See Annex 1)

Mantoux is positive if induration is:

≥10mm in a well nourished, HIV negative child

≥5mm in a malnourished, or HIV infected child

A negative Mantoux does not rule out TB (especially in the HIV positive or malnourished child)

b) Chest X-Ray

Radiological features suggestive of PTB will include:

Persistent lung opacification especially if focal

Enlarged hilar or subcarinal lymph nodes

Diffuse micronodular infiltrates (miliary pattern)

Pleural effusions

Upper lobe opacification wi t h o r wi t h o ut cavities especially in adolescents.

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Pictures suggestive of Pulmonary TB

Right perihilar lymph node

enlargement with opacity in the right

mid-zzone

Left upper lobe opacification with narrowing

and shift of left main bronchus

Miliary TB - Typical bilateral diffuse

micronodular pattern.

Note differences to LIP X-ray above

Lateral CXR showing enlarged hilar

lymph nodes (“doughnut sign”)

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Bronchiectasis: focal opacification in

right lower zone with thickening of

bronchial walls and honeycomb

appearance

Lymphoid interstitial pneumonitis:

typical features are bilateral, diffuse

reticulonodular infiltration with

bilateral perihilar lymph node

enlargement

TB pleural effusion: large right-

sided effusion. Pleural tap to

differentiate from emphysema

Spinal TB: collapse of thoracic

vertebra causing angulation

Gibbus

Pericardial TB: enlarged cardiac

shadow. Echocardiogram to

differentiate from other causes of

cardiac failure

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Summary: Simplified Clinical TB Diagnosis

Having taken history, done physical examination, Mantoux and chest x ray where available, the health worker may at

this point make a clinical diagnosis of PTB in the child as summarized below and make decisions on treatment.

Presence of 2 or more of the following symptoms

Cough > 2weeks

Weight loss or poor weight gain

Persistent fever and/or night sweats > 2 weeks

Fatigue, reduced playfulness, less active

PLUS

Presence of 2 or more of the following:

Positive contact history

Respiratory signs

CXR suggestive of PTB (where available)

Positive Mantoux test (where available)

Then PTB is likely, and treatment is justified

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ALGORITHM FOR TB DIAGNOSIS IN CHILDREN

Notes:

1. All children with TB should be tested for HIV

2. Mantoux test should be regarded as positive if:

>5mm diameter of induration in high risk children (includes HIV-infected, immune-suppressed and severely

malnourished children)

>10 mm diameter of induration in other children ( whether they have received vaccination or not)

3. Please note that a mantoux may be negative despite the child having TB especially in severe disseminated TB,

malnutrition and HIV disease.

4. Smear Positive result can be obtained from microscopy for ZN, TB culture, GeneXpert

5. A child in close contact with smear positive household member should be considered TB infected and TST may not be

necessary.

No sputum

Positive contact History

Respiratory signs

CXR suggestive of PTB (where available)

Positive Mantoux test (where available)

Treat for TB

If only one or none of the features

are present

If child is very sick, admit to

hospital for further

management

If child is not very sick, give 7 days

antibiotics then review after 1-2 weeks

If child improves, complete the treatment and

discharge home to continue with routine follow

up

If no improvement, re-evaluate for TB (May need CXR, Mantoux test etc) If TB

suspected, start TB treatment, continue regular follow up and complete the treatment

Make a diagnosis of TB if two or more of

these features are present

Sputum for bacteriology*

TB suspected based on two or more typical symptoms (Cough, fever, poor weight gain,

lethargy) for more than 2 weeks

Smear positive Smear negative

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c) Laboratory diagnosis

This can be AFB microscopy and/or Gene Xpert and/or TB culture.

As much as possible collect the appropriate specimen for diagnosis:

Suspected PTB: Sputum or gastric aspirate

Suspected EPTB: Specimen from specific site - CSF, Fine needle aspirate of lymph node, pleural

aspirate, etc (refer to table 2)

These specimens should be subjected to the appropriate test as below:

Microscopy for AFB (all specimens)

Xpert MTB/RIF (currently used only with sputum )

TB culture (all specimens from children under 5 years)

Histopathology (FNAs/biopsies)

Whenever possible, it is particularly important to make a bacteriologic diagnosis in the following situations:

Suspected drug resistant TB

Severe and complicated disease

HIV infected

Diagnostic uncertainties

When sputum should be collected for XPERT MTB/RIF/, Culture & DST

a) Contacts

Immediately a history of contact with a DRTB patient is elicited

One found to have TB symptoms during contact tracing of a DR TB patient

Before initiation of CAT 1 treatment

b) New Smear positive

Before initiation of CAT 1 treatment if:

A contact of DRTB

A Refugee

Patient on IPT who develops TB

At month 3, 4, 5 of treatment if still smear positive

c) New Smear Negative

A contact of DRTB

HIV positive

Relapse

Prior to initiation of retreatment regimen

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d) Retreatment case

Prior to initiation of retreatment regimen

At month 3 of treatment or after if the sputum prior to treatment was not taken

Return after default should have their samples collected prior to initiation of CAT 11

d) Other Tests for TB diagnosis

Radiologic tests include:

CT scan- In complicated intracranial TB (Tuberculoma)

Ultrasound – useful for abdominal TB

Laboratory tests

Nucleic acid amplification tests

Gamma interferon assays

These are mainly used in research settings.

Non specific tests like ESR and C- reactive protein tests suggest presence of inflammation if increased.

Biochemical tests – Elevated protein and low glucose levels in aspirates or in CSF suggest an exudate

e) HIV test

Making a diagnosis of HIV infection has obvious implications for the management of TB and HIV. All children with

suspected TB should be tested for HIV. (Refer to chapter 4)

Differential Diagnosis for child with Chronic Cough /Respiratory Symptoms

Other conditions to consider in a child with chronic cough /chronic respiratory symptoms who does not fulfill

the classical clinical picture of PTB include:

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Table 1: Common causes of chronic cough/ respiratory symptoms in children

Possible diagnosis Clinical Presentation

Asthma Recurrent wheeze/cough – responds to bronchodilators. Usually

associated with other allergies such as eczema, rhinitis

Upper airway conditions

Allergic rhinitis

Adenoid hypertrophy

Recurrent / persistent runny nose and /or nasal blockage and snoring

Seasonal pattern Triggers

Foreign Body Inhalation Usually sudden onset in previously well child

May have history of choking

Persistent cough

One sided respiratory signs – inspiratory stridor, wheeze

Gastro-esophageal reflux disease Recurrent cough/wheeze

Onset in early infancy

+/- hoarse voice

Bronchiectasis Severe persistent c o u g h , much sputum ( often infected green or yellow

in colour).

Finger clubbing

CXR shows reticular or honey-comb pattern

Congenital Heart Disease Easily fatigueability, breathlessness,

Onset early infancy

Acquired heart disease Older children, palpitations, easy fatiguability, dyspnoea on exertion.

+/- oedema

Congenital respiratory

disorders

Onset early infancy

Commonly premature baby

Noisy breathing during inspiration not responding to bronchodilators

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Extra Pulmonary Tuberculosis (EPTB)

Extra pulmonary TB is common in children and presentation varies with age.

In addition to fever, weight loss, lethargy lasting more than 2 weeks and history of contact, suspect extra-pulmonary

TB if the child also has clinical features suggested in the table.

Table lists typical clinical features for various forms of EPTB and suggested investigations for each category.

Symptoms are usually persistent and progressive. The most common form of EPTB is TB lymphadenitis

Table 2: Diagnosis of Extra Pulmonary Tuberculosis in Children

Site of EPTB Typical clinical presentation Investigation Comment

TB

lymphadenitis

- Asymmetrical, painless,

non-tender lymph node enlargement

for more than one month +/-

discharging sinus

-Most commonly in neck area

Fine needle

aspiration when

possible

Mantoux

Treat.

Pleural TB

Dullness on percussion

And reduced breath sounds

+/-chest pain

CXR

Pleural tap1

-If pleural fluid is straw

colored, treat for TB.

-If pleural tap reveals pus

consider Empyema and refer

TB meningitis

Headache, irritability / abnormal

behaviour, lethargic / reduced level of

consciousness, convulsions, neck

stiffness, bulging fontanel, cranial

nerve palsies

-Lumbar puncture

to obtain CSF2

-Infants-cranial

ultrasound

-Older child do CT

scan brain

- Mantoux test

Hospitalise for TB

treatment

Miliary TB Non-specific, lethargic, fever, wasted -CXR

- Mantoux test

Treat and refer3

where appropriate

Abdominal TB

Painless abdominal

swelling with ascites

-Ascitic tap1

-Abdominal ultra-

sound4

-Mantoux test

Refer3 where

appropriate

Spinal TB

-Painless deformity of spine

-May have lower limb

weakness/paralysis

-Lateral X-ray

spine

- Mantoux test

Refer where appropriate

3

Pericardial TB

-Cardiac failure

-Distant heart sounds

-Apex beat difficult to palpate

-CXR

-Echocardiogram

- Mantoux test

Refer3 where

appropriate

TB bone and joint

( excluding spine)

-Painless, non-tender swelling end of

long bones with limitation of movement

-Painless, non-tender unilateral effusion

of usually knee or hip

-X-ray of

affected bone

and/or joint

-Joint tap

- Mantoux test

Refer3 where

appropriate

1Typical findings: straw coloured fluid, exudates with high protein, white blood cells especially

lymphocytes

2Require 2 - 5ml of CSF.

3Referral may be necessary for investigation procedure and laboratory support as well as clinical care. If

referral is difficult or not readily available, start anti-TB treatment.The above table highlights the more

common forms of EPTB; however TB may infect other organs.

4Abdominal ultra-sound illustrates abdominal lymphadenopathy and shows complex ascites +/- septation

All specimens (FNA, CSF, aspirates etc) should be sent for AFB microscopy and TB

culture

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Clinical assessment in all cases of EPTB should consider:

Time lapse from exposure to disease presentation can be quite variable – shorter for

young children with disseminated disease, longer for other forms that present in school-

aged children

Common symptoms present in most cases of EPTB include fever, weight loss/poor

weight gain, and lethargy/reduced play lasting > 2weeks. Symptoms and signs

specific to the site of EPTB as shown in the table below

Investigations for TB as appropriate according to site of infection (see table 2)

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Chapter 3: Treatment of Tuberculosis

The main objectives of anti- TB treatment in children are to:

Cure the child of TB

Prevent death from TB

Prevent the complications arising from TB disease

Prevent TB relapse by eliminating the dormant bacilli

Prevent the development of drug resistance by using a combination of drugs

Decrease TB transmission to others

Some of the important points to note about TB treatment in children are:

Children usually have paucibacillary disease, as cavitating disease is relatively rare (about

6% or less) in children under 13 years of age and the majority of the organisms in adult-

type disease are found in cavities.

Children develop extra-pulmonary TB (EPTB) more often than do adults.

Severe and disseminated TB (e.g., TB meningitis and miliary TB) occur especially in

young children (less than 3 years old).

Treatment outcomes in children are generally good even in the HIV infected provided

treatment is started promptly.

Children generally tolerate the anti- TB drugs better than adults.

3.1 Classification of TB in Children

TB is generally classified as either pulmonary tuberculosis (PTB) or extra- pulmonary tuberculosis

(EPTB). For each case, the patient is either a new TB case (one who has never previously received

TB treatment for a month or longer) or a retreatment case (one who has previously been treated for

TB for one month or longer in the past).

It can also be classified according to severity as in table 3 below.

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Table 3: TB Classification in children

1. Non Severe TB

Pulmonary TB without extensive parenchymal lung disease

TB lymphadenitis

TB pleural effusion

2. Severe TB

PTB with extensive parenchymal lung disease

Miliary TB

TB bone or joint TB meningitis Pericardial TB Abdominal TB

All other forms of extra-pulmonary TB

3. Retreatment

4. Multi-drug resistant TB

Standard Operating Procedures for Treatment

Classify the case of child TB before starting treatment into pulmonary or extra-pulmonary,

new or retreatment. For extra-pulmonary forms, specify the site.

Record the TB diagnostic category, treatment regimen and date anti-TB treatment

was started on road-to-health book as well as on TB treatment card and facility TB register

A caregiver should be identified as the DOT supporter for all ages including older

children. Educate the DOT supporter on anti-TB regimen and adherence

Take the child’s weight at each visit and record

Calculate drug dosages at every visit according to the child’s current weight (note that

children gain weight while receiving anti-TB treatment)

Once treatment is started it must be completed; “trial of TB treatment” should never be

used as a diagnostic tool

Treatment regimens by disease category are listed in table 4 below.

3.2 Recommended Treatment Regimens

Table below shows the currently recommended TB treatment regimen in children

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Table 4: WHO Recommended Treatment Regimen

TB disease category Recommended regimen

Intensive phase Continuation phase

All forms of TB except TB

meningitis, bone and joint TB

(osteoarticular TB)

2* RHZE 4 RH

TB meningitis

Bone and joint TB

2 RHZE 10 RH

**Retreatment 3 RHZE 5 RHE

Drug resistant TB Refer to a DRTB specialist

*Numeral refers to number of months of the regimen e.g. 2 HRZE refers to two months of Isoniazid,

Rifampicin, Pyrazinamide and Ethambutol

H= Isoniazid

R= Rifampicin

Z= Pyrazinamide

E= Ethambutol

Table 5: Dosage of Individual anti-TB drugs according to body weight

Drug Recommendations

Average dose in mg/kg

Range in

mg/kg

Maximum Dose

Isoniazid 10 10 – 15 300 mg

Rifampicin 15 10 – 20 600 mg

Pyrazinamide 35 30 – 40 1.5 g

Ethambutol 20 15 – 25 1.6 g

Other important observations to note include:

Treatment regimens are the same for HIV-infected and HIV-uninfected children

Response to treatment in HIV infected may be slower.

Report all children receiving anti-TB treatment to the National TB Program

TB drugs are very well tolerated in children

Side-effects may occur but are not common. The most important is hepatotoxicity

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Ethambutol can be safely used in all children of all ages at recommended dosages of 20

mg/kg.

3.3 Additional Management Decisions

a) Hospitalization:

The following categories of children with TB should be treated as in- patients

Severe forms of PTB and EPTB (e.g. Spinal TB) for further investigation and initial

management.

TB meningitis

Severe malnutrition for nutritional rehabilitation

Signs of severe pneumonia (i.e. chest in-drawing)

Other co-morbidities e.g. severe anaemia

Social or logistic reasons to ensure adherence

Severe adverse reactions such as hepatotoxicity

b) Steroid therapy:

This should be given in the following situations:

TB meningitis

PTB with respiratory distress

PTB with airway obstruction by hilar lymph nodes

Severe Miliary TB

pericardial effusion

Give prednisone at 2mg/kg once daily for 4 weeks, and then taper down over 2 weeks (1mg/kg for

7 days, then 0.5mg/kg for 7 days)

c) For all HIV-infected children

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Commence Cotrimoxazole prophylaxis (25 – 30mg/kg once daily, or see table 7 for dose in

weight bands)

Commence antiretroviral therapy within 2 – 8 weeks of starting anti-TB therapy

Conduct family-based care/screening for HIV

d) Immune re-constitution inflammatory syndrome (IRIS)

This is a paradoxical deterioration after initial improvement following treatment initiation.

Seen during the initial weeks of TB treatment with initial worsening of symptoms due to

immune re-constitution. IRIS is commonly seen in the severely immuno-compromised TB/HIV

co- infected child after initiating ARV treatment.

Management: Continue anti-TB therapy; give non steroidal anti- inflammatory drugs or/and

prednisone until severe symptoms subside.

e) Referral of children with TB should be considered if

Child has severe disease

Diagnosis is uncertain

Necessity for HIV-related care e.g. to commence ART

Failure to respond to treatment despite good adherence

f) Pyridoxine

Give pyridoxine 5 – 10 mg once daily to:

All malnourished children throughout the anti-TB therapy.

HIV infected children

Breast feeding infants.

Pregnant Adolescents

3.4 Follow-up of a Child on anti-TB Therapy

This is a critical part of effective TB treatment.

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Patients visit the health facility weekly during intensive phase and every two weeks during

continuation phase. During the visit, the child should be assessed for:

Adherence

Drug toxicity

Weight gain

Symptom assessment

Sputum should be taken for AFBs at months 2 , 4 and 6 for those who were smear positive

at the beginning of treatment.

The following should be done at each visit:

Weigh the child at each visit. Document the weight and adjust dosage if necessary

Address Adherence issues

Explain and emphasize to care-giver and child why they must take the full course of

treatment even if they are feeling better

Note risk factors for poor adherence such as long distance to health facility, lack

of/transport costs, orphan ( especially if mother has died) or primary care-giver unwell and

adolescents

Education and adherence support especially TB/HIV. Explain that anti-TB drugs in children

are well tolerated and safe.

CXR is not required in follow-up if the child is responding well to anti-TB treatment

3.5 Poor Response to Treatment

Most children with TB will start to show signs of improvement within 4 – 8 weeks of anti-

TB treatment. Weight gain is a sensitive indicator of good response to treatment.

Potential causes of poor response to treatment include:

Poor adherence; this should be evaluated and problems addressed. HIV infection

Wrong diagnosis

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Other concurrent chronic lung diseases

Under dosage of drugs Resistant form of TB Complications e.g. neurological

complications

Consider treatment failure if child is receiving anti-TB treatment and:

There is no symptom resolution or symptoms are getting worse. In this case, always confirm

adherence is good. If uncertain, a child can have health care worker DOT at the health

facility

There is continued weight loss

If smear positive at baseline and remains smear positive up to 5 months

Refer children with suspected treatment failure for further assessment

3.6 Treatment Interruptions

If a child interrupts anti-TB treatment for a period less than 1 month, continue with

their TB treatment when they resume.

If the child interrupts anti-TB therapy for a period longer than 1 month, put them on a re-

treatment regimen when they resume (Table 5).

3.7 Side effects of anti TB drugs in children

The most important side-effect is hepatitis which may present with nausea and vomiting. Presence of

abdominal pain, jaundice and tender enlarged liver suggest severe hepatotoxicity. Stop the anti-TB

drugs immediately and refer to hospital.

INH may cause symptomatic pyridoxine deficiency, particularly in severely malnourished children

and HIV infected children on highly active antiretroviral therapy (HAART). Supplemental pyridoxine

is recommended.

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Chapter 4: TB and HIV Co-infection

HIV infection is one of the risk factors associated with development of Tuberculosis in children.

HIV influences TB in several ways:

Reactivation of Latent TB infection

Rapid progression of new TB infection to TB disease. Recurrence of TB after successful

treatment. Increased risk of adverse reactions to anti-TB drugs Increased risk of death

Increased risk of other infectious diseases including invasive pneumococcal disease

HIV infected children may have multiple and concurrent opportunistic lung infections that

clinically present like TB, thus making the diagnosis of TB in a HIV infected child more difficult.

The ARVs and anti -TB drugs have potentially significant drug-drug interactions as well as

overlapping toxicities that pose additional challenges.

Therefore comprehensive approach to management of both TB and HIV is critical.

4.1 Diagnosis

Approach to diagnosis of TB in HIV infected children is similar as for HIV uninfected

children. History of contact with TB is extremely important in pointing to possibility of TB disease

in the HIV infected child.

The clinical presentation of TB is similar between those in early stages of HIV disease and those

without HIV. However, those with advanced HIV disease may not have the typical TB clinical

features, and chronic respiratory symptoms may be due to other causes (see table 6).

HIV test is indicated in all children with suspected TB.

TST (Mantoux test) may be negative.

CXR may be difficult to interpret.

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4.2 Treatment

TB in HIV infected children should be treated with a 6 month regimen as in HIV- uninfected

children.

Response to TB treatment may be slow

All children with TB/HIV should receive co-trimoxazole prophylaxis. All children with TB/HIV

should receive antiretroviral therapy. Nutritional support is often needed for children with TB/HIV.

The management of children with TB/HIV should be integrated so that all family members are

counseled and tested for HIV and screened for TB. ARVs should be initiated within 2-8 weeks of

starting anti-TB therapy

4.3 Prevention

All HIV-infected children need to be screened for TB. All HIV infected children exposed to sputum

smear positive TB case should be evaluated for TB disease and treated or o ffered Isoniazid

preventive therapy at 10mg/kg/day for 6 months.

All TB infected children should be offered counseling and testing for HIV infection Known

HIV infected children should minimize their exposure to other patients with chronic cough (e.g.

separate waiting area, or fast track their consultation from the waiting area.).

The specific needs of each family should be determined and a plan of action developed to ensure

that the family receives comprehensive care using all available services.

Deliberate efforts be made to expand the prevention of mother to child transmission.

BCG vaccine to be given to all new born babies except those with symptoms of HIV infection or

those on IPT.

Always examine the placenta for tubercles as their presence may implicate vertical TB transmission.

4.4 Differential Diagnosis in HIV infected Child with Chronic

Respiratory Symptoms

The diagnosis of PTB can be particularly challenging in HIV-infected child because of clinical and

radiological overlap with other HIV-related lung disease.

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The respiratory system is a common site for many opportunistic infections in HIV infected children.

Often there is co-infection as well, which further complicates the diagnosis, other possible causes of

chronic lung disease in HIV infected children are shown in table 6.

Table 6: Causes of chronic respiratory symptoms in HIV infected children

Differential Diagnosis Clinical features

Recurrent pneumonia Recurrent episodes of cough, fever and fast breathing that

usually respond to antibiotics

LIP

Slow onset cough associated with generalized symmetrical

lymphadenopathy, finger clubbing, parotid enlargement.

Nutritional status variable, mild hypoxia CXR: diffuse

reticulonodular pattern and bilateral perihilar adenopathy

Tuberculosis

Persistent respiratory symptoms not responding to

antibiotics. Often poor nutritional status; positive TB contact

especially in younger children

CXR: focal abnormalities and perihilar adenopathy

Bronchiectasis

Cough, productive of purulent sputum, halitosis, finger clubbing,

seen in older children.

CXR: honeycombing usually of lower lobes

Complicates recurrent bacterial pneumonia, LIP or TB

PCP

Common cause of acute severe pneumonia, severe hypoxia

especially in infants. Unusual after 1 year.

CXR: diffuse interstitial infiltration, hyperinflation

Mixed infection

Common problem: LIP, bacterial pneumonia, TBConsider when

poor response to first-line empiric management

Kaposi sarcoma

Uncommon

Characteristic lesions on skin or palate

4.5 Antiretroviral Therapy in HIV Infected Children with

Tuberculosis

Tuberculosis is an increasingly common opportunistic infection in HIV-infected children. HIV

infection increases a child’s risk of progressive primary tuberculosis and reactivation of latent TB in

the older child.

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The pill burden in TB/HIV co-infection is large. Intensive adherence support and monitoring should

be offered. The risk of adverse drug reactions is increased during concomitant therapy. Perform a full

clinical evaluation at every clinic visit and if there are symptoms suggestive of adverse drug reactions,

particularly liver toxicity, refer the child.

If significant problems are experienced such as severe drug intolerance or erratic adherence, continue

the anti-TB, but consider interrupting ART. Resume after the problem has been adequately addressed

(may occasionally have to wait until completion of anti-TB therapy).

The principles of treatment of tuberculosis in HIV-infected children are similar to those in HIV-

negative children, and the same regimens should be used as those used in HIV negative children.

Recent data suggest that early initiation of HAART early in TB treatment reduces TB morbidity and

mortality, without excess adverse events.

Any child with active tuberculosis should begin TB treatment immediately; and begin ART as soon as

the TB treatment is tolerated; i.e. no nausea or vomiting and no on-going or evolving adverse drug

events, usually 2 to 8 weeks into TB therapy.

The TB/HIV co-infected child has not only diagnostic but also drug management challenges. There

are significant drug-drug interactions between the ARVs and anti-TB medications, overlapping

toxicities between these two classes of medications and a high pill burden.

Rifampicin interacts with both PIs and NNRTIs, reducing their blood levels and hence their

effectiveness. Therefore, when treating TB and giving concurrent ART, the ART regimen may

require adjustment.

ART options with Rifampicin are limited and are based on the various scenarios as indicated.

EFV based ART

Super boosted LPV with ritonavir during TB treatment and revert to the normal LPV/r

dosing after completion of TB treatment.

Triple nucleosides- Triple nucleoside ART is a weak ART combination.

Use of AZT+ABC+3TC may lead to accumulation of mutations including M184V and thymidine

analogue mutations among others. It should be used only when other options are not indicated or

available or when preferred option is not tolerated.

After completion of TB treatment with triple nucleoside ART, never restart NNRTI based ART

regimen. Instead the child should be changed to LPV/r based ART.

Scenario A: Child develops TB before Initiating ART

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Start anti-TB treatment immediately and ART within 2 – 8 weeks of starting anti- TB therapy.

A child who is severely ill needs to be started on ART sooner (within 2 weeks). A child who is less

severely ill may be started on ART within 2 - 8 weeks.

The ART options are as shown below:

NVP exposed NVP non- exposed

Irrespective of age and

weight

< 3years and <10kg > 3 years and >10 kg

Preferred option:

ABC/AZT + 3TC +

LPV/r + RTV (add extra

dose of RTV to make

the LPV/RTV ratio 1:1-

super boosted LPV)

Preferred option:

ABC/AZT + 3TC + LPV/r + RTV

(add extra dose of RTV to make

the LPV/RTV ratio 1:1- super

boosted LPV)

After completion of the TB

treatment, child can be started on

ABC/AZT+3TC+NVP

ABC/AZT+3TC+EFV

Alternative Option:

ABC+3TC+AZT

Change ART to

AZT+3TC+ LPV/ r

after completion of TB

treatment

Alternative Option:

ABC+3TC+AZT

Change ART to AZT +3TC+

LPV/ after completion of TB

treatment

Continue ART

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Scenario B: Child develops TB during the first 6 months of first-line ART

Start TB treatment immediately and also change ART regimen as indicated below.

NVP exposed NVP non- exposed

Irrespective of age and

weight

< 3years and <10kg > 3 years and >10 kg

Preferred option:

ABC/AZT + 3TC +

LPV/r + RTV (add extra

dose of RTV to make the

LPV/RTV ratio 1:1-super

boosted LPV)

Preferred option:

ABC/AZT + 3TC + LPV/r + RTV

(add extra dose of RTV to make

the LPV/RTV ratio 1:1- super

boosted LPV)

After completion of the TB

treatment, child can be restarted on

original 1st

line i.e.

ABC/AZT+3TC+NVP

ABC/AZT+3TC+EFV

Alternative Option:

ABC+3TC+AZT

Change ART to AZT

+3TC+ LPV/r after

completion of TB

treatment

Alternative Option:

ABC+3TC+AZT

Change ART to AZT +3TC+

LPV/r after completion of TB

treatment

Continue ART

Scenario C: Child develops TB while on 1st line ART for more than 6 months

There is the possibility that this new episode of TB is an indication of poor response to ART due to

non-adherence or of ARV treatment failure or both. Manage as follows:

Initiate anti-TB treatment immediately.

Evaluate adherence to ART and ensure that any problems in adherence have been addressed

before embarking on a second-line regimen ART.

Evaluate for treatment failure for all.

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The ART options are as shown below:

NVP exposed* NVP non- exposed

Irrespective of age and

weight

< 3years and <10kg > 3 years and >10 kg

Preferred option:

ABC/AZT + 3TC + LPV/r

+ RTV(add extra dose of

RTV to make the

LPV/RTV ratio 1:1- super

boosted LPV)

Preferred option:

ABC/AZT + 3TC +LPV/r + RTV (add extra

dose of RTV to make the LPV/RTV ratio

1:1-super boosted LPV).

If there is no ART failure, after completion

of the TB treatment, child can be restarted on

original 1st

line i.e. ABC/AZT+3TC+NVP

ABC/AZT+3TC+EFV

Alternative Option:

ABC+3TC+AZT

Change ART to

AZT+3TC+ LPV/r after

completion of TB

treatment

Alternative Option:

ABC+3TC+AZT

Change ART to AZT +3TC+ LPV/r after

completion of TB treatment

Continue ART

If child is confirmed to have failed first line LPV/r based ART, continue failing regimen and consult

therapeutic committee for future ART options

Scenario D. Child develops TB while on 2nd

line ART regimen

Anti-TB therapy should be started immediately.

There is the possibility that this new episode of TB is an indication of poor response to ART due to

non-adherence, or of ARV treatment failure, or both. If treatment failure is confirmed, do not

discontinue ART. In addition their future management of ART should be discussed with a senior

consultant with expertise in the management of HIV infection and the National HIV Therapeutics

Committee.

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The ART option is as shown below:

Scenario ART options

Child on second line LPV/r

based ART

Preferred option:

ABC/AZT + 3TC + LPV/r + RTV (add extra dose of RTV to make

the LPV/RTV ratio 1:1-super boosted LPV.

Change to normal LPV/r dose after completion of TB treatment

Alternative option:

3TC monotherapy.

Restart original ART after completing TB treatment.

4.5 Cotrimoxazole Preventive Therapy (CPT)

Cotrimoxazole has been shown to reduce mortality among children infected with HIV. All TB/HIV

co-infected children should be offered CPT and it should be started as soon as possible. The duration

of treatment is usually indefinite with a once daily dosing.

The children should be monitored for side effects which include skin rashes and gastrointestinal

disturbances. Severe adverse reactions are uncommon and usually include extensive exfoliative rash,

Steven Johnson syndrome or severe anemia / pancytopenia. CPT should be discontinued if a child

develops severe adverse reactions.

Table 7: Recommended doses for cotrimoxazole.

Weight

in Kg

Child

Suspension

(200mg/40m g

per 5ml)

Child Tablet

(100mg/20mg)

Single strength

adult tablet

(400mg/80mg)

Double strength

adult tablet

(800mg/160mg)

<5 2.5 ml One Tablet ¼ tablet -

5-15 5 ml Two tablets ½ tablet -

15-30 10ml Four tablets One tablet ½ tablet

>30 - - Two tablets One tablet

Triple nucleoside ART should NOT be used in TB/HIV co-infected patients who have

previously failed ART

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4.6 IPT in Children

Children living with HIV who are more than 12 months of age, who are unlikely to have active TB

on symptom-based screening and have no contact with a TB case should receive six months of

IPT (10 mg/kg/ day) as part of a comprehensive package of HIV prevention and care services.

In children living with HIV who are less than 12 months of age, only those who have contact with a

TB case, and who are evaluated for TB (using investigations) should receive six months of IPT if the

evaluation shows no TB disease.

Table 8: Dose and duration of Isoniazid (INH) for Isoniazid preventive Therapy (IPT) in

children

INH 10 mg/kg/day for 6 months (maximum 300 mg/day).

Weight (kg) Daily Dose in mg Number of 100 mg tablets

<5 50 ½

5.1 – 9.9 100 1

10-13.9 150 1½

14-19.9 200 2

20-24.9 250 2½

>25 300 3*

For children more than 25 kg, one can use 1 adult tablet of 300mg INH once daily.

Table 9: Give IPT with Pyridoxine at the following doses:

Weight (kg) Number of tablets of pyridoxine (50mg)

5-7 Quarter tablet daily

8-14 Half tablet daily

15 and above One full tablet daily

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Chapter 5: TB in special circumstances

5.1 TB Meningitis (TBM)

TB meningitis is common in young children and is associated with high morbidity and mortality

particularly if the diagnosis is delayed. It is therefore important to consider a diagnosis of TBM in

young children as early as possible, especially in children who have a history of contact with an

adult with infectious TB.

Miliary or haematogenously disseminated TB has a high risk (60–70%) of meningeal

involvement. For this reason, all children with Miliary TB (or suspected of having Miliary TB)

should undergo a lumbar puncture to exclude TB meningitis.

Clinical presentation of TBM is usually insidious and one must have a high index of suspicion all

the time.

Treatment

Children with TB meningitis or Miliary TB should be hospitalized, preferably for at least the first 2

months or until they have clinically stabilized. TB Meningitis is one of the severe forms of

TB and therefore four anti-TB drugs (RHZE) are recommended for the intensive phase.

Isoniazid and Rifampicin are used for the continuation phase. The continuation phase is longer i.e.

given for 10 months instead of 4 months.

Corticosteroids (usually prednisone) are recommended for all children with TB meningitis at a

dose of 2 mg/kg daily for 4 weeks. The dose should then be gradually reduced (tapered) over 1–

2 weeks before stopping.

5.2 Management of a Newborn born to a Mother with PTB

Once a pregnant woman has been on anti- TB treatment for at least 4 weeks before

delivery she is generally no longer infectious and is therefore unlikely that her baby will become

infected. A newborn infant has a high risk of infection/ disease from a mother with smear-

positive pulmonary TB if the mother is diagnosed at delivery or soon thereafter.

If the mother is diagnosed with TB shortly before delivery, then the baby and possibly the

placenta should be investigated for evidence of congenital TB infection. The neonate

should be screened for TB. Signs and symptoms of Neonatal TB disease are usually non

specific and may include, fever, feed intolerance, poor weight gain, hepato-splenomegally and

irritability (symptoms of neonatal sepsis).

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Those that are symptomatic should be treated for TB.

Those without active TB disease should be on IPT for 6 months.

If child had not received BCG by the time of instituting IPT, BCG should be withheld until 2

weeks after completion of IPT. Breast feeding can be safely continued during this period. Mother

is then educated on Infection Prevention measures she can institute to prevent TB transmission at

home.

If mother has MDR-TB, then IPT is not useful due to resistant bacilli, and in this scenario, BCG

should be given at birth, and neonate is handled as an MDR contact.

5.3 Drug Resistant TB

Resistance to Rifampicin and/or Isoniazid is the most important, as these two

drugs form the backbone of the current TB chemotherapy.

Mono- and poly-resistance

One can develop resistance to one or more anti-TB drug at a time. The treatment varies with the

resistance pattern. The table below outlines the treatment options for children with various TB drug

resistance patterns.

Table 10: Patterns of drug resistance and recommended treatment

Pattern of drug resistance Regimen Duration of treatment

H (±S) R/Z/E/LFX 9 Months

H, E, Z (±S) 3Cm-Lfx-R-Z / 15 Lfx-R-Z** 18 Months

H and Z 3Cm-Lfx-R-Z / 15 Lfx-R-Z** 18 Months

H and E 3Cm-Lfx-R-Z/ 15 -Lfx-R--Z** 18 months

R 8Cm-Pto-Lfx-Cs-Z / 12 Pto-Lfx-Cs-Z* 20 months

R and E (± S) 8Cm-Pto-Lfx-Cs-Z/ 12 Pto-Lfx-Cs-Z* 20months

R and Z (± S) 8Cm-Pto-Lfx-Cs-Z/ 12 Pto-Lfx-Cs-Z* 20 months

* The patient should be started on MDR regimen and another sample collected for DST

**Consider a patient’s previous drug history between the time of sample collection and results being

received before starting the patient on the recommended regimen.

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Multidrug-resistant TB

MDR-TB is resistance to both Isoniazid and Rifampicin, with or without resistance to other anti-TB

drugs. MDR-TB in children is mainly the result of transmission of a strain of M. tuberculosis that is

MDR from an adult source case, and therefore often not suspected unless a history of contact with

an adult pulmonary MDR-TB case is known. The diagnosis of MDR needs DST and its treatment

is difficult. Referral to a specialist is always advised.

Some basic principles of treatment of MDR are as follows:

Do not add a drug to a failing regimen.

Treat the child according to the drug susceptibility pattern and use the treatment history

of the source case’s M. tuberculosis strain if an isolate from the child is not available.

Use at least four drugs certain to be effective.

Use daily treatment only; directly observed therapy is essential.

Counsel the child’s caregiver at every visit, to provide support, advice about adverse

events and the importance of compliance and completion of treatment.

Follow-up is essential: clinical, radiological and bacteriological (mycobacterial culture

for any child who had bacteriologically confirmed disease at diagnosis).

Treatment duration depends on the extent of the disease, but in most cases will be 20

months or more (or at least 12 months after the last positive culture).

With correct dosing, few long-term adverse events are seen even with the more toxic

second line drugs in children, including Ethionamide and the Fluoroquinolone.

Children with MDR-TB should be treated with the first-line drugs to which their M. tuberculosis

strain (or that of their source case) is susceptible to, including streptomycin, Ethambutol and

Pyrazinamide. Ethambutol is bactericidal at higher doses, so daily doses up to 25 mg/kg should be

used in children being treated for MDR-TB.

Extreme Drug resistant TB (XDR)

By definition XDR is MDR TB that is also resistant to a second line injectable anti- TB drugs and

any Fluoroquinolone. Compared to MDR it is even more difficult to treat and mortality is very high.

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Chapter 6: TB Prevention

6.1 Screening for Child Contacts of Known TB Cases

Young children living in close contact with an index case of smear positive pulmonary TB

are at a high risk of TB infection and disease. The risk of infection is greatest if the contact is

close and prolonged. The risk of developing disease after infection is much greater for

malnourished children, children under 5 years and HIV infected children than it is for HIV un-

infected children and those over 5 years. If the disease develops it usually does so within 2 years of

infection, but in infants the time lag can be as short as a few weeks.

Isoniazid preventive therapy (IPT) for young children with infection who have not yet developed

disease will greatly reduce the likelihood of developing TB during childhood.

The main purpose of child contact screening is to:

1. Identify symptomatic children (i.e. children of any age with undiagnosed TB disease) and treat

them for TB.

2. Provide Isoniazid preventive therapy (IPT) for the high risk children who have no signs or

symptoms of TB disease i.e

All children aged under 5 years

All HIV infected children

The best way to detect TB infection is the TST, and CXR is the best method to screen for TB

disease in symptomatic children contacts who are not able to produce sputum for AFB microscopy.

Where these two tests are unavailable contact screening and management can be conducted on

the basis of a simple clinical assessment.

Generally clinical assessment is sufficient to decide whether the contact is well or symptomatic.

Contact screening refers to the screening or evaluation for TB infection or

disease of all close contacts of smear positive PTB index case

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Symptoms for Child Contact Screening

1. Non remitting cough for more than 2 weeks

2. Persistent fever for more than 2 weeks

3. Loss of weight/poor weight gain

4. Lethargy/malaise/reduced play

5. Enlarged cervical LN

IPT should be given at a dose of 10mg/kg for duration of 6 months.

Children on IPT should receive monthly follow up. During the follow up visit:

Continuously reinforce message of adherence

Screen for TB disease i.e. persistent cough, fever, lethargy, poor weight gain

Monitor INH adverse effects.

Maintain a contact register

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6.2 Management of child exposed to PTB

The algorithm below outlines the management of a Child who has been exposed to an

adolescent or adult with Pulmonary TB

Any child who is symptomatic should be evaluated for TB disease and treated

*Asymptomatic HIV negative child not on IPT should be followed up every 3 months for at least 1

year

Parent should be advised to bring the child to the hospital any time the child develops symptoms

Child exposed to an adolescent or adult with

Pulmonary TB

Under 5 years of age Aged 5 years and above

Symptomatic e.g. cough,

poor weight gain, fever,

lethargy Asymptomatic

Asymptomatic

Evaluate for TB

and treat

accordingly

No IPT

IPT (6 months INH)

If becomes symptomatic

while on IPT

If becomes symptomatic

HIV

negative*

HIV

Positive

IPT (6

months INH)

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Child contact known to be HIV-infected

If the child contact is HIV-infected and asymptomatic, then IPT should be considered for all

ages, including those 5 years and older. As with other contacts, active disease should be ruled out

before providing HIV-infected children with IPT. HIV infected children who have symptoms

should be carefully evaluated for TB, and if found to have TB should be started on TB treatment.

Suspected HIV infection of contact

If the index case is a parent and is HIV infected, their children may be at risk of both TB and HIV

infection. It is important to counsel and test for HIV as we screen for T B in fec t io n i n a l l

t h e c o n t a c t s . (Consider joint T B /HIV co ntac t investigations)

Child contacts of infectious MDR-TB cases

By definition MDR-TB is resistance to both Isoniazid and Rifampicin. Therefore, it is unlikely

that use of these drugs to treat latent infection caused by a resistant M. Tuberculosis strain

will prevent the development of active TB disease. Close contacts of MDR-TB patients should

receive careful clinical follow-up for a period of at least 2 years. If active disease develops, prompt

initiation of treatment of the child with a regimen designed to treat MDR-TB is recommended.

The regimen is usually based on the resistance pattern of the MDR TB index case.

The use of second-line drugs for chemoprophylaxis in MDR-TB contacts is currently not

recommended.

6.3 Tracing of TB Source

Where the child is the first person in the household diagnosed to have TB, the household members

and other close contacts of the child should be evaluated in order to identify the index case of TB.

Evaluation should include screening for classic TB symptoms: cough, fever, weight loss and lethargy.

Note: The index case may have transmitted TB to the child several months earlier, and may not

currently be living in the household.

6.4 BCG Vaccination in Children

BCG is a live attenuated vaccine derived from M. bovis. It offers protection against the more

severe types of TB such as Miliary TB and TB meningitis, which are common in young

children.

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All children should be given the BCG vaccine as soon as possible after birth EXCEPT those with

suspected TB infection at birth. The BCG vaccination should then be deferred till 2 weeks after

IPT/ TB treatment.

A child who has not had routine neonatal BCG immunization and has symptoms of HIV disease/

congenital immunodeficiency syndrome should also not be given BCG because of the risk of

disseminated BCG disease.

A small number of children (1–2%) may develop complications following BCG

vaccination. These commonly include:

Local abscesses at the injection site

Secondary bacterial infections

Suppurative adenitis in the regional axillary lymph node

Local keloid formation.

Disseminated BCG disease. If axillary node enlargement is on the same s i d e a s BCG in a

HIV- positive infant, consider BCG disease and refer.

Most reactions will resolve spontaneously over a few months and do not require specific treatment.

Children who develop disseminated BCG disease should be investigated for immunodeficiencies

and treated for TB using a 4-drug first-line regimen: 2RHZE t h e n 4 R H (The BCG b a c i l l u s

h a s p o o r s u s c e p t i b i l i t y t o Pyrazinamide).

6.5 TB Infection Control

Prevention of TB transmission and infection in the household and health facilities are important

components of control and management of TB in children.

The following simple procedures are effective in TB infection control at home and clinics:

Early diagnosis and management of adult TB cases in the household

At the clinic promptly identify potential and known infectious cases of TB; separate and

treat them with minimal delay by conducting triage and screening

Provide health education about TB transmission without stigmatizing TB

patients

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Encourage proper cough hygiene both at home and at health facilities

Natural ventilation and sunlight:

Keep doors and windows open on opposite sides of the TB clinic and other clinics where

children and adults stay together open to bring in air from the outside.

Advise TB patients to do the same at home

Advise patients and household members to allow sunlight into their ho use (rooms) by

o peni ng the doors and windows

Apply the same in the clinics

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Chapter 7: Roles and Responsibility

7.1 Level 1: (family, patient, CHW, CHEW, community)

Tuberculosis is an infectious disease, which is transmitted from one person to another through

coughing, sneezing etc. A patient may infect other people who may also develop tuberculosis.

The patient should, therefore, encourage other people with whom he or she has been is in close

contact with to undergo screening for TB.

The TB patient should be encouraged to spend more time in open space so as to reduce indoor

transmission

Children, parents, and other family members should be educated about TB and the importance of

completing treatment. Where possible, someone other than the child’s parent or immediate family

member should observe or administer treatment.

The communities should ensure:

Children get all the primary vaccines.

The chronic coughers to be screened for TB. Those on treatment adhere to treatment.

TB patients who develop complications to be referred to higher level for

evaluation and treatment

7.2 Level 2 and 3: Dispensary and Health Centre

Diagnose children with TB based on signs and symptoms, tuberculin skin test to be done if

possib le . In these leve ls , i t may be poss ib le to conduct smear microscopy and initiate TB

treatment based on the results.

7.3 Level 4, 5 and 6: District, County and Referral Hospitals

These levels provide referral services for lower levels where diagnosis is not possible or for

further management due to complications that may develop in a child started on treatment at

lower levels. At these levels, correct diagnosis through microscopy or bacteriology is done.

Initiation of treatment for all forms of TB is usually started at these levels before referral to lower

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levels. Generally, these levels diagnose children based on signs and symptoms, tuberculin skin test,

microscopy, chest x-ray and culture and eventually initiate treatment.

7.4 Follow-up

Each child should be clinically assessed a very 2 weeks during the intensive phase, and

every month during the continuation phase until treatment completion. The assessment

should include, at a minimum:

Symptom assessment

Assessment of adherence by reviewing the treatment card

Inquiry about any adverse events

Weight measurement

Drug dosage adjustment to account for any weight gain

A follow-up sputum smear for microscopy at 2 months should be obtained for any child who was

smear-positive at diagnosis. Follow-up chest radiographs are not routinely required in children,

who are improving on treatment as radiological changes usually lag behind clinical response

A child who is not responding to TB treatment should be referred for further assessment and

management (Level 4, 5 and 6).

7.5 Health education

It is the responsibility of health staff to educate tuberculosis patients and their relatives about

their disease. It is essential to obtain the patient's co-operation over the required treatment. An

understanding, sympathetic and concerned attitude on the part of the health staff is essential for

getting the message across.

Health education is a prerequisite for high cure rates and default prevention. It should be provided

every time the patient receives care from the health care provider and should focus on improving

adherence and detecting any untoward events that may compromise the health of the child.

Always remember that medication dosages should be adjusted to account

for any weight gain

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In addition, health education should be able to detect any index case that may be in the family.

7.6 Case recording and reporting for childhood TB

All children diagnosed and treated for TB should be recorded in the TB facility register and

standard treatment outcomes reported.

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Chapter 8: Child nutrition and TB

Malnutrition is an important public health issue particularly for children under five years

old who have a significantly higher risk of mortality and morbidity than well nourished children. In

Kenya, the infant and the under-five mortality rates are 77 and 115 per 1000 live births respectively.

The national figure for acute malnutrition of children under five years old is estimated at 6%1.

Malnutrition is defined as “a state when the body does not have enough of the required

nutrients (under-nutrition) or has excess of the required nutrients (over-nutrition). There are two

categories of malnutrition: Acute Malnutrition and Chronic Malnutrition.

Children can have a combination of both acute and chronic. Acute malnutrition is categorized into

Moderate Acute Malnutrition (MAM) and Severe Acute Malnutrition (SAM), determined by the

patient’s degree of wasting. All cases of bi-lateral oedema are categorized as SAM.

Chronic malnutrition is determined by a patient’s degree of stunting, i.e. when a child has not reached

his or her expected height for a given age. To treat a patient with chronic malnutrition requires a long-

term focus that considers household food insecurity in the long run; home care practices (feeding and

hygiene practices); and issues related to public health.

SAM is further classified into two categories: Marasmus and Kwashiorkor. Patients may

present with a combination, known as Marasmic Kwashiorkor. Patients diagnosed with

Kwashiorkor are extremely malnourished and at great risk of death.

Admission criteria for acute malnutrition are determined by a child’s weight and height, by

calculating weight-for-height as “z-score” (using WHO Child Growth Standard, 2006)2, and

presence of oedema. All patients with bi-lateral oedema are considered to have severe acute

malnutrition. See Table 11for anthropometric criteria.

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Table 11: Anthropometric criteria to identify severe, moderate and at risk categories of acute

malnutrition for Children and Adolescents*

Indicator Severe Acute

Malnutrition

(SAM)

Moderate Acute

Malnutrition (MAM)

At Risk of Acute

Malnutrition

Infants less than 6 months

W/L

W/L < - 3 Z-Score Static weight or losing

weight at home Static weight or

losing

weight at home

Z-Score Oedema Oedema Present Oedema Absent Oedema Absent

Other signs

Too weak to suckle or

feed Poor feeding Poor feeding

Children 6 months to 10 years

W/H Z-

Scores

< -3 Z-Score Between -3 to < -2

ZScore Between -2 to <-1

Z-Score MUAC (6 - 59

months only) <11.5cm 11.5 to 12.4cm 12.5-13.4cm

Oedema Oedema Present Oedema Absent Oedema Absent

Adolescent (10 years to 18 years)

MUAC < 16cm N/A N/A

Oedema Oedema Present Oedema Absent Oedema Absent

*Anthropometric criteria based on WHO Child Growth Standards (2006)

Mid-Upper Arm Circumference (MUAC) is often the screening tool used to determine malnutrition

for children in the community under five years old. A very low MUAC (<11.5cm for children under

five years) is considered a high mortality risk and is a criteria for admission with severe acute

malnutrition. See Table 12 below for MUAC criteria for children under-five years.

Table 12: MUAC criteria to identify malnutrition of children under five years in the community

Severely Malnourished Moderately

Malnourished

At Risk of malnutrition

less than 11.5cm 11.5cm to 12.4cm 12.5cm to 13.4cm

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Table 13: Triage to determine treatment of either severe or moderate malnutrition

ASK:

1. Has there been any weight loss in previous month?

2. Does the patient have an appetite.

3. Does the patient have any medical condition that will

impair

nutritional status?

4. Is the breast-feeding child suckling well?

LOOK AND FEEL FOR: Visible signs of wasting

CHECK:

MUAC

Weight

Height/length

Bilateral-oedema

DETERMINE: Level of malnutrition using W/H reference charts

LOOK AT SHAPE OF GROWTH

CURVE:

1. Has the child lost weight?

2. Is the growth curve flattening?

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Annex 1: Tuberculin Skin Test (Mantoux test)

Administering, reading and interpreting a tuberculin skin test

A TST is the intradermal injection of a combination of mycobacterial antigens which elicit an

immune response (delayed-type hypersensitivity), represented by in duration, which can be measured

in millimeters. The TST using the Mantoux method is the standard method of identifying people

infected with M. tuberculosis. Multiple puncture tests should not be used to determine whether a

person is infected, as these tests are unreliable (because the amount of tuberculin injected

intradermally cannot be precisely controlled).

Details of how to administer, read and interpret a TST are given below, using 5 tuberculin units (TU)

of tuberculin PPD-S. An alternative to 5 TU of tuberculin PPD-S is 2 TU of tuberculin PPD RT23.

Administration

1. Locate and clean injection site 5–10 cm (2–4 inches) below elbow joint

Place forearm palm-side up on a firm, well-lit surface.

Select an area free of barriers (e.g. scars, sores) to placing and reading. Clean the area with an alcohol

swab.

2. Prepare syringe

Check expiration date on vial and ensure vial contains tuberculin PPD-S (5

TU per 0.1 ml).

Use a single-dose tuberculin syringe with a short (¼- to ½-inch) 27-gauge needle with a short bevel.

Fill the syringe with 0.1 ml tuberculin.

3. Inject tuberculin (see Figure A1.1)

Insert the needle slowly, bevel up, at an angle of 5–15 °. Needle bevel should be visible just below

skin surface.

4. Check injection site

After injection, a flat intradermal wheal of 8–10 mm diameter should appear. If not, repeat the

injection at a site at least 5 cm (2 inches) away from the original site.

5. Record information

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Record all the information required by your institution for documentation (e.g. date and time of test

administration, injection site location, lot number of tuberculin).

Figure A1.1 Administration of the tuberculin skin test

Reading

The results should be read between 48 and 72 hours after administration.

A patient who does not return within 72 hours will probably need to be rescheduled for another TST.

1. Inspect site

Visually inspect injection site under good light, and measure induration (thickening of the

skin), not erythema (reddening of the skin).

2. Palpate induration

Use fingertips to find margins of induration.

3. Mark induration

Use fingertips as a guide for marking widest edges of induration across the forearm.

4. Measure diameter of induration using a clear flexible ruler

Place “0” of ruler line on the inside-left edge of the induration.

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Read ruler line on the inside-right edge of the induration (use lower measurement if between two

gradations on mm scale).

5. Record diameter of induration

Do not record as “positive” or “negative”. Only record measurement in millimeters. If no induration,

record as 0 mm.

Figure A1.2 Reading of the tuberculin skin test

Interpretation

TST interpretation depends on two factors:

Diameter of the induration.

Person’s risk of being infected with TB and risk of progression to disease if infected.

Mantoux is positive if induration is:

10mm in a well nourished, HIV negative child

5mm in a malnourished, or HIV infected child

A negative mantoux does not rule out TB (especially in the HIV positive or malnourished child)

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Annex 2: Sputum Collection

Procedures for obtaining clinical samples for smear

microscopy

This annex reviews the basic procedures for the more common methods of obtaining clinical

samples from children for smear microscopy: expectoration, gastric aspiration and sputum

induction.

Expectoration

Background

All sputum specimens produced by children should be sent for smear microscopy and, where

available, mycobacterial culture. Children who can produce a sputum specimen may be infectious,

so, as with adults, they should be asked to do this outside and not in enclosed spaces (such as

toilets) unless there is a room especially equipped for this purpose. Three sputum

specimens should be obtained: an on-the-spot specimen (at first evaluation), an early

morning specimen and a second on the- spot specimen (at follow-up visit).

Procedure [adapted from Laboratory services in tuberculosis control. Part II. Microscopy (1)]

1. Give the child confidence by explaining to him or her (and any family members) the

reason for sputum collection.

2. Instruct the child to rinse his or her mouth with water before producing the specimen. This will

help to remove food and any contaminating bacteria in the mouth.

3. Instruct the child to take two deep breaths, holding the breath for a few seconds after each

inhalation and then exhaling slowly. Ask him or her to breathe in a third time and then forcefully

blow the air out. Ask him or her to breathe in again and then cough. This should produce sputum

from deep in the lungs. Ask the child to hold the sputum container close to the lips and to spit into

it gently after a productive cough.

4. If the amount of sputum is insufficient, encourage the patient to cough again until a satisfactory

specimen is obtained. Remember that many patients cannot produce sputum from deep in the

respiratory track in only a few minutes. Give the child sufficient time to produce an expectoration

which he or she feels is produced by a deep cough. If there is no expectoration, consider the

container used and dispose of it in the appropriate manner.

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Gastric aspiration

Background

Children with TB may swallow mucus which contains M. tuberculosis. Gastric aspiration is a

technique used to collect gastric contents to try to confirm the diagnosis of TB by microscopy and

mycobacterial culture. Because of the distress caused to the child, and the generally low yield

of smear-positivity on microscopy, this procedure should only be used where culture is available as

well as microscopy. Microscopy can sometimes give false-positive results (especially in HIV-infected

children who are at risk of having non-tuberculous mycobacterium). Culture enables the

determination of the susceptibility of the organism to anti-TB drugs.

Gastric aspirates are used for collection of samples for microscopy and mycobacterial cultures in

young children when sputa cannot be spontaneously expectorated nor induced using hypertonic

saline. It is most useful for young hospitalized children. However, the diagnostic yield (positive

culture) of a set of three gastric aspirates is only about 25–50% of children with active TB, so a

negative smear or culture never excludes TB in a child. Gastric aspirates are collected from

young children suspected of having pulmonary TB. During sleep, the lung’s mucociliary system

beats mucus up into the throat. The mucus is swallowed and remains in the stomach until the

stomach empties. Therefore, the highest-yield specimens are obtained first thing in the morning.

Gastric aspiration on each of three consecutive mornings should be performed for each patient.

This is the number that seems to maximize yield of smear- positivity. Of note, the first gastric

aspirate has the highest yield.

Performing the test properly usually requires two people (one doing the test and an assistant).

Children not fasting for at least 4 hours (3 hours for infants) prior to the procedure and

children with a low platelet count or bleeding tendency should not undergo the procedure.

The following equipment is needed:

• Gloves

• Nasogastric tube (usually 10 French or larger)

• 5, 10, 20 or 30 cm3 syringe, with appropriate connector for the nasogastric tube

• litmus paper specimen container

• Pen (to label specimens)

• Laboratory requisition forms

• Sterile water or normal saline (0.9% NaCl) Sodium bicarbonate solution

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• (8%) Alcohol/chlorhexidine.

Procedure

The procedure can be carried out as an inpatient first thing in the morning when the child wakes up,

at the child’s bedside or in a procedure room on the ward (if one is available), or as an

outpatient (provided that the facility is properly equipped). The child should have fasted for at

least 4 hours (infants for 3 hours) before the procedure.

1. Find an assistant to help.

2. Prepare all equipment before starting the procedure.

3. Position the child on his or her back or side. The assistant should help to hold the child.

4. Measure the distance between the nose and stomach, to estimate distance that will be required to

insert the tube into the stomach.

5. Attach a syringe to the nasogastric tube.

6. Gently insert the nasogastric tube through the nose and advance it into the stomach.

7. Withdraw (aspirate) gastric contents (2–5 ml) using the syringe attached to the nasogastric tube.

8. To check that the position of the tube is correct, test the gastric contents with litmus paper:

blue litmus turns red (in response to the acidic stomach contents). (This can also be checked by

pushing some air (e.g. 3–5 ml) from the syringe into the stomach and listening with a

stethoscope over the stomach.)

9. If no fluid is aspirated, insert 5–10 ml sterile water or normal saline and attempt to aspirate

again.

• If still unsuccessful, attempt this again (even if the nasogastric tube is in an incorrect

position and water or normal saline is inserted into the airways, the risk of adverse

events is still very small).

• Do not repeat more than three times.

10. Withdraw the gastric contents (ideally at least 5–10 ml).

11. Transfer gastric fluid from the syringe into a sterile container (sputum collection cup).

12. Add an equal volume of sodium bicarbonate solution to the specimen (in order to neutralize

the acidic gastric contents and so prevent destruction of tubercle bacilli).

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After the procedure

1. Wipe the specimen container with alcohol/chlorhexidine to prevent cross- infection and label

the container.

2. Fill out the laboratory requisition forms.

3. Transport the specimen (in a cool box) to the laboratory for processing as soon as possible

(within 4 hours).

4. If it is likely to take more than 4 hours for the specimens to be transported,

place them in the refrigerator (4–8 °C) and store until transported.

5. Give the child his or her usual food.

Safety

Gastric aspiration is generally not an aerosol-generating procedure. As young children are also at

low risk of transmitting infection, gastric aspiration can be considered a low risk procedure for TB

transmission and can safely be performed at the child’s bedside or in a routine procedure room.

Sputum Induction

Note that, unlike gastric aspiration, sputum induction is an aerosol-generating procedure. Where

possible, therefore, this procedure should be performed in an isolation room that has adequate

infection control precautions (negative pressure, ultraviolet light (turned on when room is not in

use) and extractor fan).

Sputum induction is regarded as a low-risk procedure. Very few adverse events have been

reported, and they include coughing spells, mild wheezing and nosebleeds. Recent studies

have shown that this procedure can safely be performed even in young infants (2), though

staff will need to have specialized training and equipment to perform this procedure in such patients.

General approach

Examine children before the procedure to ensure they are well enough to undergo the

procedure.

Children with the following characteristics should not undergo sputum induction.

Inadequate fasting: if a child has not been fasting for at least 3 hours, postpone the

procedure until the appropriate time.

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Severe respiratory distress (including rapid breathing, wheezing, hypoxia).

Children who are intubated.

Bleeding: low platelet count, bleeding tendency, severe nosebleeds

(symptomatic or platelet count <50/ml blood).

Reduced level of consciousness.

History of significant asthma (diagnosed and treated by a clinician).

Procedure

1. Administer a bronchodilator (e.g. salbutamol) to reduce the risk of wheezing.

2. Administer nebulized hypertonic saline (3% NaCl) for 15 minutes or until 5 cm3 of

solution have been fully administered.\

3. Give chest physiotherapy is necessary; this is useful to mobilize secretions.

4. For older children now able to expectorate, follow procedures as described in section A

above to collect expectorated sputum.

5. For children unable to expectorate (e.g. young children), carry out either: (i) suction of

the nasal passages to remove nasal secretions; or (ii) nasopharyngeal aspiration

to collect a suitable specimen.

Any equipment that will be reused will need to be disinfected and sterilized before use for a

subsequent patient.

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Annex 3: Seven Steps for Patient Management to

prevent transmission of TB in Community and health

care settings

Step Action Description

1. Screen -Early identification and detection of patients with suspected or confirmed TB disease is the first

step in the protocol. It can be achieved by assigning a staff member in a health facility and

trained community health workers to screen patients for prolonged duration of cough and take

immediate action. -Patients with cough of more than two weeks duration, or who report being

under investigation or treatment for TB*, should not be allowed to wait in the line with other

patients to enter, register, or get a card.

-The patients under investigation and on treatment should be weighed in the treatment room and

not referred to the MCH/FP (well baby clinic) where mothers and infant are waiting Instead;

they should be managed as outlined below.

-Likewise patients with similar prolonged cough should be immediately being referred to a health

facility. Carry out contact tracing of sputum positive PTB including MDR and XDR TB. Actively track

the defaulters and bring them back to treatment. 2. Educate Educating the above-mentioned persons identified through screening, on cough etiquette and

respiratory hygiene. This includes instructing them to cover their noses and mouths when coughing

or sneezing, and when possible providing facemasks, handkerchiefs or tissues to assist them in covering

their mouths.

3. Special

waiting areas

Patients who are identified as TB suspects or cases by the screening questions should be directed

to another separate waiting room away from other patients and requested to wait in a separate well-

ventilated waiting area, and provided with a surgical mask or tissues to cover their mouths and noses

while waiting.

4. Triage Patients in special groups (known HIV positive, the very young and old) should be given

preference in care. Triaging symptomatic patients to the front of the line for the services should

be done. In an integrated service delivery setting known HIV patients should be separated from

smear positive TB patients. Known HIV positive clients in the community should be frequently be

monitored for TB and referred promptly.

5. Investigate

for TB or

Refer

TB diagnostic tests should be done onsite or, if not available onsite, the facility should have an

established link with a TB diagnostic and treatment site to which symptomatic patients can be

referred.

6. Treatment Appropriate TB treatment should be initiated in accordance with National TB guidelines at

the earliest time possible. Directly obse rved t h e r a p y ( DOT) to ensure adherence to treatment.

Follow-up and monitor patients in accordance with National TB guidelines.

Conduct additional diagnostic procedures to ensure the appropriate treatment is given (both for TB

t r e a t m e n t a s we l l as p o t e n t i a l i n t e r a c t i on s wi t h other medications such as ARVs).

Document completion of treatment program.

7. Discharge

Plan

For i n p a t i e n t a n d o u t p a t i e n t s e t t i n g s , c o o r d i n a t e a discharge plan with the patient

(including a patient who is a HCW with TB disease) and the TB-control program of the local,

district or provincial health facilities. If applicable, co-management o f p a t i e n t s w i th H I V or

other diseases should be coordinated with the applicable local, district or provincial

health facilities. For MDR-TB, identify trained HW in referral sites who will be able to manage the

patient according to the national multi-drug-resistant TB guidelines.

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Annex 4: Dosages for Paediatric TB treatment using dispersible FDC tablets of RHZ,

RH and single Ethambutol tablets for NEW CASES

Table A1: Child between 5 and 22 kg

Intensive phase (2 months RHZE) Continuation phase (4 months RH)

Weight band

(kg)

No. of tablets of RHZ

(60/30/150mg)

No. of tablets of RH

(60/60mg)

Ethambutol

(100mg)

No. of tablets of

RH (60/30mg)

No. of tablets of

RH (60/60mg)

5 - 7 1 1 1 2 0

8- 14 2 1 2 2 1

15 -22 3 2 3 3 2

Table A2: Child between 23 and 30 kg

NOTE: For children above 30kg, do not give RH 60/60 but treat as adults

All children must be on pyridoxine 1-2mg/kg/day

Intensive phase (2 months RHZE) Continuation phase (4 months RH)

Weight band

(kg)

No. of tablets of RHZE

(150/75/400/275mg)

No. of tablets of RH

(60/60mg)

No. of tablets of RH

(150/75mg)

No. of tablets of RH (60/60mg)

23-30 2 2 2 2

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Annex 5: Dosages for Paediatric TB treatment using dispersible FDC tablets of RHZ, RH

and single Ethambutol tablets for RETREATMENT CASES

Table B1: Child between 5 and 22 kg

Intensive phase (3 months RHZE) Continuation phase (5 months RHE)

Weight

band (kg)

No. of tablets of RHZ

(60/30/150mg)

No. of tablets of

RH (60/60mg)

Ethambutol

(100mg)

No. of tablets of

RH (60/30mg)

No. of tablets of

RH (60/60mg)

No. of tablets of

Ethambutol (100mg)

5 - 7 1 1 1 2 0 1

8- 14 2 1 2 2 1 2

15 -20 3 2 3 3 2 3

Table B2: Child between 23 and 30 kg

For children above 30kg, do not give RH 60/60 but treat as adults

All children must be on pyridoxine 1-2mg/kg/day throughout the course of anti-TB treatment

Do not use Streptomycin for TB retreatment in children. If a child on retreatment is not improving at one month of treatment assess for adherence and

rule out drug resistant TB

NOTE: Use of streptomycin on retreatment cases among the children is discouraged

Intensive phase (3 months RHZE) Continuation phase ( 5 months RHE)

Weight band

(kg)

No. of tablets of RHZE

(150/75/400/275mg)

No. of tablets of

RH (60/60mg)

No. of tablets of

RH (150/75mg)

No. of tablets of

RH (60/60mg)

No. of tablets of

Ethambutol (400mg)

23-30 2 2 2 2 1

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Annex 6: Child Tuberculosis Monitoring Card E

NR

OL

ME

NT

NAME:

Gender: Male / Female

AGE: years months

DOB:_ _ / _ _ /

TB Registration No: Other factors:

Malnutrition: Y / N

Nutritional

supplement:

Food/Micronutrients

HIV test:

Positive/Negative/Not

done

Date:

CPT: Y/N

Date:

ART Y/N

Date:

Primary Caregiver Name:

Relationship to child:

TEL. NO.

Physical Address:

MUAC:

Weight in kg:

Height or Length of child in cm:

< 5yr: weight for age: Normal /

Low

>5yr: BMI for age: Normal / Low

SITE OF TB (Tick what applies)

PTB EPTB

TYPE OF TB (Tick what applies)

New Retreatment

smear positive

Retreatment

smear negative

Return after

Default Smear

positive

Return after

default smear

negative

Transfer in

Regimen (Circle)

2RHZE 4RH

3RHZE 5RHE

2RHZE 10RH

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Drug collection schedule

Intensive phase Date started: Continuation phase Date started:

Date drugs were

collected

Date drugs were

collected

Date drugs were

collected

Date drugs were

collected

Week 1 Week 7 Week 1& 2 Week 13 & 14

Week 2 Week 8 Week 3 & 4 Week 15 & 16

Week 3 Week 9 Week 5 & 6 Week 17 & 18

Week 4 Week 10 Week 7 & 8 Week 19 & 20

Week 5 Week 11 Week 9 & 10

Week 6 Week 12 Week 11 & 12

Date treatment was completed:

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FO

LL

OW

-UP

Phase in Treatment Start of

Treatmen

t

Month

1

Month

2

Month

3

Month

4

Month

5

Month

6

Month

7

Month

8

Month 9 Month 10 Final

Review

Outcome

VISIT DATE (DD/MM/YY)

Weight (kg)

TB DRUGS: INDICATE THE NUMBER OF TABLETS AT EVERY VISIT

Paed RHZ (60/30/150mg)

Paed RH (60/ 60mg)

Paed RH (60/ 30mg)

Ethambutol (100mg)

Ethambutol (400mg)

RHZE

(150/75/400/275mg)

RH (150/75mg)

Vitamin B6 (50mg)

Any Adverse Effect (specify)

Any TB doses missed in past month

(Y/N)

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Annex 7: Second-line anti-TB drugs for treatment of

MDR*-TB in children

Table C: Second-line anti-TB drugs for treatment of MDR-TB in

children

Drug Mode of action Common side effects Recommended daily

dose (mg/Kg body

weight)

Maximum

daily dose

(mg)

Ethionamide or

Prothionamide

Bactericidal Vomiting,

gastrointestinal upset

15–20 1000

Fluoroquinolone***

Ofloxacin Levofloxacin

Moxifloxacin Gatifloxacin

Ciprofloxacin

Bactericidal

Bactericidal

Bactericidal

Bactericidal

Bactericidal

Arthropathy,

arthritis

15–20

7.5–10

7.5–10

7.5–10

20–30

800

1500

Aminoglycosides

Kanamycin Amikacin

Capreomycin

Bactericidal

Bactericidal

Bactericidal

Ototoxicity,

hepatotoxicity

15–30

15–22.5

15–30

1000

1000

1000

Cycloserine or Terizidone Bacteriostatic Psychiatric, neurological 10–20 1000

Para-Aminosalicylic

acid

Bacteriostatic Vomiting,

Gastrointestinal upset

150 12 000

* MDR- multi drug resistant

*** Although Fluoroquinolone are not approved for use in children in most countries, the benefit of

treating children with MDR-TB with a Fluoroquinolone may outweigh the risk in many instances.

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Annex 8: Taking Anthropometric Measurements

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Annex 9: Growth monitoring charts

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