Interim Guidelines in the Management and Prevention of Ebola Virus Disease as of 12012014

2RESEARCH INSTITUTE FOR TROPICAL MEDICINE

Good newsTo date, the Philippines remains EVD-free.

2

All 24 samples tested in RITM were

NEGATIVE.

3 asymptomatics – negative

1 urolithiasis

19 malaria

1 hypertensive emergency

DEPARTMENT OF HEALTH

RESEARCH INSTITUTE FOR TROPICAL

MEDICINE

Interim Guidelines on the Management and Prevention of

Ebola Virus DiseaseIn consultation with

Philippine Society for

Microbiology and

Infectious Diseases

Arthur Dessi Roman, MD, MTM, FPCP, DPSMID

PSMID 36th Annual Convention

November 28, 2014


Scope of the Guideline

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Risk stratification

and Recommended

Action

Screening and

Triage Diagnostics

Therapeutic strategies

Case definitions

Home monitoring

and isolation


Objectives• To familiarize the participants with the process of screening

and triage for EVD

• To provide basic knowledge on the available diagnostics and therapeutic strategies for EVD

• To stratify the risk level for EVD transmission based on the nature of exposure of persons and provide recommendations for activities and monitoring

• To give an overview on infection control and prevention strategies in the management of EVD cases

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Disclaimer 1

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Warning:Lecture NOT intended to make you intensivists.


Disclaimer 2

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Lecture NOT intended to make you a ONE-MAN EBOLA FIGHTING MACHINE


Disclaimer 3

Ebola is an evolving disease.

Interim guidelines change as new information becomes available.

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Keep yourself updated!


Outline• Case definitions

• Laboratory testing

• Screening and triage

• Monitoring of PUI

• Clinical Management

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Case Definitions

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Person Under Investigation (PUI)

Any person who has resided in or traveled to any of the countries with ongoing widespread EVD transmission

in the past 21 days

OR

Any person who had significant contact with a suspect/probable/confirmed case in the past 21 days

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Asymptomatic+

Epidemiologic risk factor

13RESEARCH INSTITUTE FOR TROPICAL MEDICINE 1313


Site of the 2014 Western Africa Ebola outbreak


Country Classification

16http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/case-

counts.html


What is significant contact?

Exposure to a suspect/probable/confirmed EVD case in at least one of the following ways:

• Sleeping in the same household

• Direct physical contact (while alive, during illness or after demise)

• Touched blood or body fluids during the illness;

• Touched the clothes/linen of the case during his or her illness;

• Being breastfed

• Direct handling of bats, rodents, or primates from disease-endemic areas

• Direct contact with specimens collected from an EVD patient or animal

• Has worked in a hospital where EVD cases are being treated.

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Suspect Case

• fever (actual or reported)

• headache

• nausea/ vomiting

• anorexia/loss of appetite

• intense fatigue

• Diarrhea

• abdominal pain

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• muscle or joint pains

• difficulty swallowing or sore throat

• difficulty in breathing

• drowsiness or lethargy

• bleeding (from different sites such as gums, skin, eyes, urine, etc.)

• hiccups

PUI+

Signs and symptoms


Probable EVD Case

Any suspected case evaluated by a clinician/epidemiologist having an epidemiological link with a confirmed case (where it was possible to collect specimen for laboratory confirmation).

OR

Any deceased suspected case (where it was not possible to collect specimen for laboratory confirmation) having an

epidemiological link with a confirmed case

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Laboratory Confirmed EVD Case

A suspected case with laboratory confirmation of infection with EVD.

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Laboratory confirmation is done by the RITM Special

Pathogens Laboratory and Molecular Biology Laboratory.

The sample must test positive for the Ebolavirus antigen by

RT PCR.


Discard/ Non-EVD Case

A suspected case with a negative laboratory result that was from a blood specimen collected

72 hours after onset of symptoms.

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Laboratory testing for EVD

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Antigen Antibodies

ELISA RT-PCR ELISA


Martines et al. J Pathol 2014

Asymptomatic patients are not contagious!

Course of EVDNo virus before

symptoms


Recommendation: EVD Testing

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EVD test on admission

Confirmed EVD case

Positive YES

Done 72 hrs after onset of

illness?

Negative NO Asymptomatic?

Alternative Dx?

NO

Repeat EVD test 72 hrs after onset

of illnessPositive

YES

Non-EVD

Negative







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Screening and Triage

To quickly identify people with a travel history to affected countries and provide proper home advice or

promptly isolate them if symptomatic

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Guidelines on Screening and Triage

• All health care facilities MUST designate a triage area.• Screen at all points of entry to health facility (to catch every patient

and visitors)• Train screening staff on what to say; e.g., Have you traveled

overseas in the last 21 days? Did you travel to (name countries with Ebola)?.

• Train screening staff on what to do when a PUI is identified (include contact numbers)

• Identify holding and isolation areas and who will perform further assessment of the patient.

• Ensure necessary precautions are observed.– Perform hand hygiene frequently– Follow standard precautions and wear the complete recommended

personal protective equipment (PPE) if there is any potential for contact with infectious blood and body fluids

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Screening / Triage tent at RITM

• Separate from the general ER to prevent potential transmission to other patients and hospital staff.

• Should be located as near as possible to the Ebola isolation unit of the hospital to prevent patients from gaining access to the whole hospital facility.

• The area should have adequate ventilation and room air exchange.

• Maintain minimum 1 meter distance from patients

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Entrance to Isolation

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Stairs going to isolation room

32RESEARCH INSTITUTE FOR TROPICAL MEDICINE 32Antechamber to isolation area


Screening and Triage: Case

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Travel

History

Contact

History

Fever or

other

symptoms

Assessment Testing for

EVD

Disposition

- - +Not considered for EVD No Treat per normal procedures

- + -PUI No Active monitoring for symptoms for 21 days

± Home quarantine based on risk level

+ - -PUI No Active monitoring for symptoms for 21 days


+ + -PUI No Active monitoring for symptoms for 21 days


- + +Suspect EVD Case Yes Admit to isolation room

Manage Appropriately

+ - +Suspect EVD Case Yes Admit to isolation room


+ + +Suspect EVD Case Yes Admit to isolation room



Screening and Triage: Case

Amy and Gino, both 38, are a newly-wed couple who arrived home from an African adventure trip today. They started their trip 20 days ago and have visited the following countries: South Africa, Botswana, Liberia, Senegal. Amy came to the hospital seeking contraceptive advice.

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PPE for Ebola• Repeated training is necessary

• Trained observer or “buddy” is

• Composed of:– Double gloves

– Boot covers

– Single-use impermeable (waterproof) gown or coverall

– Respirators (including either N95 respirators or powered air purifying respirator [PAPR])

– Single-use, full-face shield

– Hoods to ensure complete coverage of the head and neck

– Waterproof apron to cover the body up to the level of the calf.

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Who should wear PPE?• Persons who will have close contact with a person

with Ebola who has symptoms (e.g., doctors or nurses who will take care of Ebola patients)

• Persons who will have contact with patients withoutsymptoms (e.g., travelers without symptoms who are staying at home after returning from Ebola-affected countries)

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Who should not wear PPE?


Martines et al. J Pathol 2014

No virus before

symptoms

Asymptomatic patients are not contagious!

Why?







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Monitoring of PUIs

Active monitoring

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Active monitoring through direct observation (actual patient visit)

DOH personnel (such as members of the Regional Surveillance Units) will actively communicate with the PUIs and perform the twice daily assessment for the presence of symptoms and fever,

rather than relying solely on individuals to self-monitor and report symptoms if they develop

Direct active monitoring


Monitoring of PUIs

Quarantine

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separation of a symptomatic individual reasonably believed to be infected with EVD from those not

infected to prevent spread of the disease

Isolation

separation and restriction of the movement of healthy people who were exposed to a contagious disease to

see if they become sick


Monitoring of PUIs

Home quarantine

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staying at home and limiting

unnecessary travel or contact with the general community


Monitoring of PUIs

Home quarantine

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To prevent the possible spread if the person

becomes sick with Ebola during travel.

To avoid unnecessary exposure to other local

diseases that may mimic some symptoms of

EVD

Audience participation:

These patients are asymptomatic.

Why do you have to separate themselves???


Monitoring of PUIs

Home quarantine

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Includes restricted public activities


Monitoring of PUIs

• PUI symptomatic SUSPECT isolate admit

• Isolation precaution at once

– Isolate yourself inside a room

– No kissing, hugging or laying of hands

– Avoiding contact with body fluids

– Immediately place all used clothes and linen in a plastic bag . DO NOT dispose of this yourself, but inform DOH regarding its disposal.

– Inform DOH immediately.


Monitoring of PUIsThe following persons are NOT at risk of getting Ebola:

• Those who have been in a country with widespread Ebola transmission (Guinea, Liberia, Sierra Leone) or Mali

– Since MORE THAN 21 days ago

– with no symptoms of Ebola since leaving any of these countries.

• Aircraft or ship crew members who did not leave the immediate area of the airplane/ship and had no direct contact with anyone from the community during the entire time that they were present in a country with widespread Ebola virus transmission

• Contact with a healthy person with NO symptoms who had contact with a person with Ebola.

• Contact with a person with Ebola BEFORE the person developed symptoms.

• Those who have been in places WITHOUT widespread Ebola transmission (e.g. Spain, Texas, New York).


Monitoring of PUIsPeople with LOW (BUT NOT ZERO) risk:

NO direct contact with body fluids from a person with Ebola.

Brief proximity, such as being in the same room for a brief period of time, with a person with Ebola who has symptoms.

Traveled on an aircraft with a person with Ebola who has symptoms.

People with MODERATE RISK:

Direct contact, while using appropriate PPE, with a person with Ebola who has symptoms, or with the person’s body fluids.

Directly took care of patients in other healthcare settings.

With close contact in households, healthcare facilities, or the community, WITHOUT appropriate PPE, with a person with Ebola who

has symptoms. Close contact means being within approximately 3 feet (1 meter) of a person with Ebola for a long time.

People at HIGH RISK:

Exposed to blood or body fluids of a person with Ebola who has symptoms, through broken skin (like a wound or a needle prick) or

mucus membranes (such as splashes to the eyes, nose or mouth).

Exposed to the blood or body fluids (including but not limited to feces, saliva, sweat, urine, vomit, breast milk, and semen) of a

person with Ebola with symptoms while not wearing appropriate PPE.

Processed blood or body fluids of a person with Ebola who has symptoms without appropriate PPE or standard biosafety

precautions.

Direct contact with a dead body without appropriate PPE

Those who live in the immediate household and provide direct care to a person with Ebola who has symptoms.


Monitoring of PUIsRISKLEVEL

RECOMMENDED ACTIONS Other comments

Monitoring Travel

Restrictions

Restricted

Public Activities

Home quarantine

NO risk No No No No Not PUIsConsult physician for the diagnosisand management of other non-Eboladiseases if symptoms develop.

LOW risk Yes--Active monitoring in

general; Direct active for special

conditions *

No No No No restrictions including work.

MODERATErisk

Yes—direct active

Conditional Conditional Conditional Imposition of restrictions will depend on certain factors**

HIGH risk Yes—directactive

Yes Yes Yes Non-congregate public activities while maintaining a 3-foot distance from others may be permitted (e.g. jogging)

* Special conditions include (1) healthcare workers caring for symptomatic Ebola patients while wearing appropriate PPE and (2) for travellers on an aircraft with, and sitting within 3 feet of, a person with Ebola**Factors include: intensity of exposure (e.g., daily direct patient care versus intermittent visits to an Ebola treatment unit); point of time in the incubation period (risk falls substantially after 2 weeks); complete absence of symptoms; compliance with direct active monitoring; the individual's ability to immediately recognize and report symptom onset, self-isolate, and seek medical care; and the probability that the proposed activity would result in exposure to others prior to effective isolation.







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Lessons Learned: Clinical Care

• In West Africa, limited clinical evaluations and essentially no laboratory testing due to the lack of any infrastructure to support this.

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Ribner BS. Treating patients with Ebola virus infections in the US: lessons

learned. Presented at IDWeek, October 8, 2014. Philadelphia PA

Wolz A. Face to Face with Ebola — An Emergency Care Center in

Sierra Leone. N Engl J Med 2014; 371:1081-1083.



• Case fatality rate: 90% 70.8-74% 50% 37%

• Fever is the most common symptom

• Predominance of gastrointestinal symptoms

• Bleeding is rare

• Patients with <100,000 EBOV copies per mL had a lower case fatality rate than those with ≥10 million EBOV copies per mL (33% vs. 94%, P = 0.003).

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1 WHO Ebola Response Team. N Engl J Med 2014;371:1481-1495.2 Schieffelin, J.S., et al., Clinical Illness and Outcomes in Patients with

Ebola in Sierra Leone. New England Journal of Medicine. 0(0): p. null.



• Significant risk factors for death:– > 45 years (OR 2.47; 95% CI, 1.79 to 3.46)

– Diarrhea (OR 1.42; 95% CI, 1.06 to 1.89)

– Conjunctivitis

– Difficulty breathing or swallowing

– Dizziness

– Weakness

– Confusion or disorientation, and coma

– Hemorrhagic symptoms• unexplained bleeding, bleeding gums, bloody nose, bleeding at the injection site

and bleeding from the vagina)

rarely reported (in <1% to 5.7% of patients)

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1 WHO Ebola Response Team. N Engl J Med 2014;371:1481-1495.2 Schieffelin, J.S., et al., Clinical Illness and Outcomes in Patients with

Ebola in Sierra Leone. New England Journal of Medicine. 0(0): p. null.



• Laboratory findings associated with a fatal outcome

– Elevated levels of BUN, AST and creatinine

• Significant findings among EVD+ patients:

– Hyponatremia (127.32 SD 0.84)

– Hypokalemia (3.67 SD 0.11)

– Hypocalcemia (7.84 SD 0.15)

– Albumin (3.34 SD 0.10)

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Schieffelin, J.S., et al., Clinical Illness and Outcomes in Patients with Ebola

in Sierra Leone. New England Journal of Medicine. 0(0): p. null.



• The Emory team observation of 2 patients:

– Severe hypovolemia low serum albumin and vascular leak with third spacing.

• Fluid losses in their patients were 5-10 L/day.

– Electrolyte losses were significant :• Low Na, K+, Ca++

• Lead to arrhythmias required IV and oral electrolyte correction

– Nutritional depletion was evident as well.

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Ribner BS. Treating patients with Ebola virus infections in the US: lessons learned. Presented

at IDWeek, October 8, 2014. Philadelphia PA


It’s not all Ebola!

Acute febrile illness

+

Travel to (West) Africa


Differential Diagnoses

• Malaria, Malaria, Malaria

• Typhoid fever

• Shigellosis

• Cholera

• Leptospirosis

• Plague

• Rickettsiosis

• Relapsing fever

• Meningitis

• Hepatitis

• Other viral hemorrhagic fevers

Source: WHO, 2014


Other Tests

• Complete blood count with platelet count

• Biochemical tests – PT, PTT, ALT, AST, BUN, creatinine, Na, K, Ca

• Blood typing

• Chest X-ray

• Malarial smear

Reference: WHO, 2014; MSF VHF Manual, 2008


Important

• Make sure that your institution is prepared to perform such tests.

– Is a protocol in place?

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Important

Reality check:

• Is your laboratory willing/ready to dedicate separate equipment or lab area to process EVD samples?

• Are your MedTechs willing/ready to do it?

• If there are spills, is your lab willing to close down for hours to decontaminate

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Important

Advantages

• Less fear among staff

• Less impact on staffing and lab operations

• STAT results?

Disadvantages

• Limited test panel

• No back-up if machine goes down

• Cost of maintaining an instrument that is rarely used

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Point of care testing

Ribner BS. Treating patients with Ebola virus infections in the US: lessons learned from

https://www.uhc.edu/25073


Treatment

• Objective: To provide optimal care to the patient with maximal protection of the health care personnel

• No FDA-approved vaccines or medicines (e.g., antiviral drug) available for Ebola.

• Treatment is mainly supportive and symptomatic.

– Fluid balance

– Nutrition

– Managing hemorrhagic complications


“Advanced” Supportive Treatment

• Maintaining adequate fluid balance– Providing IV fluid replacement and maintenance

• D5-containing fluids

• Plain crystalloid solution (LR or NSS)

– Fluid replacement should be adjusted to the hydration status and fluid requirement of the patient

• Emory’s caveat: No IV is to be started on patients unless the patient is in emergent need of volume replacement or reasonably expected to require IV medication.



• Balancing electrolytes– Monitor Na, K, Ca, q3 days or as necessary

– IV or oral correction

– WOF: arrhythmias, weakness, paresthesia, ileus (may limit PO intake)



• Management of hemorrhagic complications

– Transfusion of blood or blood components for severe bleeding and coagulation abnormalities

• May perform universal blood transfusion


Supportive Treatment

• NUTRITIONAL SUPPORT, parenteral feeding (may include glutamine) when warranted

• Maintaining blood pressure with pressors

• Antipyretic and analgesics for fever and pain. DO NOT use aspirin or other nonsteroidal anti-inflammatory agents

• Anti-emetic against vomiting

• Anxiolytics to combat anxiety

• Monitoring of kidney function and renal replacement therapy if needed.


Supportive Treatment

• Oxygen support if needed.

• Aggressive ventilatory support and invasive procedures (intubation and mechanical ventilation, etc.) may put healthcare workers at a much greater risk for exposure to the virus due to aerosolization.

• Performance of aerosol generating procedures (nebulization, BiPAP, suctioning, sputum induction) is highly discouraged.


Other Treatments

• Antibiotics for superimposed or concomittant bacterial infections. – For CA-infections, ceftriaxone/ertapenem may be used. For HA-

infections, piperacillin-tazobactam or meropenem

– Secondary peritonitis and sepsis due to the loss of mucosal integrity and bacterial translocation(1) add metronidazole?

• Empiric co-artem administration if malarial smear cannot be done.

1 Kreuels, B., et al., A Case of Severe Ebola Virus Infection Complicated by Gram-

Negative Septicemia. New England Journal of Medicine


Monitoring of Ebola tests

• Repeat Ebola antigen ELISA or RT - PCR test 72 hours after resolution of symptoms.

• If still positive, repeat the test every 3 days until 2 negative tests.

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Criteria for Discharge

Patients SHOULD ONLY be discharged if ALL of the following conditions are fulfilled:

• Two negative ELISA antigen tests

• Asymptomatic for at least 72 hours

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Follow-up

• Follow-up one week after discharge

• Repeat CBC and other blood tests that were abnormal.

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Investigational Drugs

• There have been no clinical trials of drugs in humans infected with Ebola virus

• Drugs have been used either in animal models in experimental trails and/or in individual people

• Clinical trials in humans naturally infected or exposed are needed to determine efficacy


Investigational Drugs

Cohen and Kupferschmidt. A Dose of Reality. 21 NOVEMBER 2014 • VOL 346 ISSUE 6212


Things to ponder on…

• In the clinical management of EVD, the patient may benefit more from the care of an intensivist/critical care specialist more than the expertise of an ID physician

• Remember that we are treading the unknown here…

– Notice: Clinical management in most guidelines is just ONE paragraph!

– There are many questions and issues that even experts do not have an answer.

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Things to ponder on…

• Balance between patient care and safety of HCWs

– How aggressive are you willing to go in your respective institutions?

• Intubate?

• Dialyse?

• Surgical procedures?

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Summary

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• Efficient screening and triage is important.

• Home quarantine and monitoring strategies depend on the risk level for EVD transmission.

• Cornerstone of management in EVD is “advanced” supportive therapy which include:– Fluid and electrolyte balance

– Management of hemorrhagic complications

– Other supportive treatment including nutritional support and malaria management

• Novel treatments still warrant further investigation.

• Balance between patient care and healthcare worker safety should be achieved.

• Institutions should be ready to handle specific issues that may arise in the course of management in EVD via a multidisciplinary approach.


Thank you!

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Interim Guidelines in the Management and Prevention of Ebola Virus Disease as of 12012014

Health & Medicine

Transcript of Interim Guidelines in the Management and Prevention of Ebola Virus Disease as of 12012014