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Title of study Summary and Purpose Field/research Study type Study design Intervention Study location Sponsor, collaborator and
investigator
Study population/condition Sample size Available source of
information (website, trial
identity code)
Video Directly Observed Therapy
(VDOT) to Monitor Short-Course
LTBI Treatment
A novel mHealth application that allows patients to make
and send videos of each medication dose ingested that are
watched by healthcare providers via a HIPAA-compliant
website to remotely monitor LTBI treatment adherence
(Video DOT [VDOT]) has been developed. This study will
determine whether monitoring patients with VDOT achieves
higher treatment completion rates and greater patient
acceptability at lower cost than clinic-based in-person DOT.
Adherance and completion
in treatment
Interventional Allocation: Randomized
Endpoint Classification: Efficacy
Study
Intervention Model: Parallel
Assignment
Masking: Open Label
Video Directly Observed Therapy,
In-Person DOT (Control)
USA Sponsor:
University of California, San Diego TB contacts and refugees in San
Diego who are prescribed 3HP for
LTBI treatment by their physician
will be randomly assigned to be
monitored for adherence via
either VDOT or in-person DOT
310 NCT02641106
Quantiferon Gold Test for Detecting
TB Infection in HIV/AIDS Patients in
South Africa
To compare the effectiveness of linking the Quantiferon-gold
in-tube test (QGIT) with routine CD4 testing to the routine
use of the tuberculin skin test (TST), the current standard of
care for diagnosing latent tuberculosis infection (LTBI) in
South Africa. The investigators hypothesize that QGIT clinics
will identify LTBI and initiate isoniazid preventive therapy
(IPT) in a higher proportion of patients and in a significantly
faster timeframe. The cost-effectiveness of linking QGIT
with routine CD4 compared to routine TST will also be
evaluated,
Performance of comercially
available immunotests
Interventional Allocation: Randomized
Intervention Model: Parallel
Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Device: QGIT
South Africa Sponsor:
Johns Hopkins University
Collaborators:
National Institute of Allergy and
Infectious Diseases (NIAID)
University of Witwatersrand, South
Africa
3000 NCT02119130
Vitamin D Suplementation in TB
Prevention
The goal of this clinical trial is to investigate the preventive
role of vitamin D supplementation in school age children in a
high transmission setting. The investigators hypothesis is
that (1) vitamin D supplementation will reduce rate of
acquisition of LTBI, (2) vitamin D supplementation will lead
to greater reductions in active TB incidence, and (3) children
with the lowest vitamin D status at baseline will gain most
Treatment/intervention
Interventional
Phase 3, Allocation: Randomized
Intervention Model: Parallel
Assignment
Masking: Double Blind (Subject,
Caregiver, Investigator,
Outcomes Assessor)
Primary Purpose: Prevention
•Dietary Supplement:
cholecalciferol (vitamin D)
14000 IU vitamin D3 weekly
Experimental group will receive
vitamin D supplement (Tishcon,
USA).
Not provided
Sponsor:
Harvard School of Public Health
Healthy children ages between
6 and 13 years, enrolled in
participating schools
Not currently TB infected.
8200 NCT02276755
Toward a Safe and Reachable
Preventive Therapy for LTBI: a
Multicenter Randomized Controlled
Study in Taiwan
The incidence of TB in Taiwan has gradually declined in
recent 10 years. In order to maintain the trend of decreasing
in incidence, preventive therapy for LTBI become more and
more important. However, which is the best preventive
regimen for LTBI is still unknown. Therefore, we conduct the
prospective randomized multicenter studies to compare the
treatment completion rate of two regimens in Taiwan. The
first regimen is daily isoniazid for 9 months. The second is
weekly rifapentine plus high-dose isoniazid for 3 months.
Treatment/intervention Interventional Phase 3 Allocation: Randomized
Endpoint Classification:
Safety/Efficacy Study
Intervention Model: Parallel
Assignment
Masking: Open Label
Primary Purpose: Prevention
Rifapentine and Isoniazid for 3 months
versus Isoniazid for 9 months Taiwan
Sponsor:
National Taiwan University Hospital 322 NCT02208427
Diagnosis of Active and Latent TB
Infection With IFN-y Assays in
African Children
Study based in Southern Ethiopia Purpose - to explore if
children in contact with adults with TB have positive acute
reactants such as IFN-y and other cytokine responses; if
these responses discriminate between high and low risk of
disease progression and whether these could be
incorporated into improved diagnostic approaches.
Performance of comercially
available immunotests
Observational Observational Model: Defined
Population
Time Perspective: Longitudinal
Not provided Ethiopia Sponsor:
Liverpool School of Tropical Medicine
Collaborator:
Thrasher Research Fund
Children with suspicion of TB
attending health centres will
also be investigated
500
NCT00456469
The Role of Apoptosis Associated
Markers in Pathogenesis of
Pulmonary Tuberculosis
The apoptosis-associated markers, including Fas ligand,
Decoy-receptor 3, Lipoxin, and prostaglandin E2, are
discriminative in patients with active TB from those with LTBI
and thus might predict the potential of being active TB from
LTBI. To compare the serum apoptosis-associated markers
between patients with active TB and patients with LTBI To
evaluate the efficiency of apoptosis-associated markers to
differentiate potential of active TB from LTBI
Development of new tests
with improved performance
and biomarkers
Observational Observational Model: Case
Control
Time Perspective: Prospective
Not provided Taiwan
National Taiwan University Hospital
1.Patients with tuberculosis:
microbiology or pathology
proven tuberculosis infection
2.Patients with latent
tuberculosis infection are
defined by interferon-gamma
release assay
3.Patients without tuberculosis
and latent tuberculosis are
defi=ed by negative findings in
above-mentioned results
400 NCT01676155
Prognostic Value of Interferon
Gamma Release Assays in Predicting
Active Tuberculosis Among
Individuals With, or at Risk of,
Latent Tuberculosis Infection
The objective of this study is to assess the efficacy of the two
current TB (tuberculosis) blood tests (Interferon Gamma
Release Assays (IGRA)) compared with the standard skin test
(Mantoux Tuberculin Skin Test (TST)), for predicting active
tuberculosis among those at increased risk of TB. Those at
increased risk are defined as either newly arrived immigrants
or people who have been in contact with TB cases. The study
will also provide information on the cost effectiveness of
different testing strategies, such as the two step testing
approach recommended by NICE.
Programme management Observational Observational Model: Cohort
Time Perspective: Prospective
Not provided United Kingdom Sponsor:
Public Health England
Collaborators:
Imperial College London
Queen Mary University of London
University College, London
Brunel University
University of Birmingham
Those who are close contacts
of active tuberculosis cases or
those who have are new
entrants to the UK from high
incidence countries
(>40/100000).
10000 NCT01162265
Study to Evaluate the Tolerability
and Immunogenicity of Nyaditum
Resae ® Probiotic Administered to
Pediatric Population in Contact
With Tuberculosis With or Without
Latent Tuberculosis Infection
This is a double-blind, masked, compared with placebo
clinical trial in pediatric population in contact with
tuberculosis with or without tuberculosis infection. This trial
aims to study the effect of the probiotic Nyaditum resae® at
the level of specific Treg memory cells eight weeks after the
first administration, and the global tolerability of the
treatment.
Nyaditum resae® is a preparation in the form of capsules
containing heat-killed environmental mycobacteria
Mycobacterium manresensis. The overall objective of the
study is the effect of Nyaditum resae® on immunity, which
could reduce the risk of developing active tuberculosis.
Treatment/intervention Interventional Phase 1 Allocation:
Randomized, Endpoint
Classification: Safety/Efficacy
Study, Intervention Model:
Parallel Assignment, Masking:
Double Blind (Subject, Caregiver,
Investigator), Primary Purpose:
Prevention
Dietary Supplement: Nyaditum
resae ® 10e5 of heat-killed
Mycobacterium manresensis
Other: Placebo
Spain
Sponsor:
Manresana de Micobacteriologia, SL
Child between 2 and 17 years,
who have had contact with
tuberculosis
24 NCT02581579
Immune Responses to
Mycobacterium Tuberculosis (Mtb)
in People With Latent Tuberculosis
Infection With or Without
Concomitant Helminth Infection
To study how the immune system of people with latent
tuberculosis infection (LTBI) acts to prevent development of
active TB. Also, to study how helminth infection might affect
this immune response. An exploratory objective is to
evaluate if there are subsets of subjects within the LTBI
group (irrespective of helminth infection status) who have
stable pool of long lasting antigen-specific IL-2 only
producing CD4+ central memory T cells and changes to this
pool after receiving LTBI treatment.
Other (immunology,
pathogenesis, co-infection)
Observational
Study Design:
Time Perspective: Prospective
United States Sponsor: National Institute of Allergy
and Infectious Diseases (NIAID)
The study will enrol
participants with LTBI250 NCT02225158
Randomised controlled trial for cost-
benefit of short-course isoniazid
and rifapentine versus 9-month
course of isoniazid in latent
tuberculosis infection
The aim of this study is to perform a multimodal comparison
of 3-month courses of weekly isoniazid and rifapentine (3HP)
with 9 months of daily isoniazid (9H) for latent tuberculosis
infection, using a variety of indices:
a. Cost-benefit
b. Patient satisfaction
c. Adherence to prescribed therapy
Programme management Interventional Randomised controlled trial
Parallel
Phase: Phase 4
A 12 dose course of weekly
isoniazid (900mg) and rifapentine
(900mg) tablets.
Australia Sponsor: Hospital Melbourne Health
Persons with clinical indication
for latent tuberculosis infection
(LTBI) treatment.
80 ACTRN12613000599774
Effect of Filarial Infection on
Immune Responses in Latent
Tuberculosis
Researchers want to study people with latent tuberculosis
(TB) who may or may not be infected with filariasis. This
study will look at the way that people with latent TB fight
infection with these worms.
Other (immunology,
pathogenesis, co-infection)
Observational Time Perspective: Cross-Sectional not provided United States Sponsor:
National Institute of Allergy and
Infectious Diseases (NIAID)
Eligibility:
- Individuals between 18 and
65 years of age who have
latent TB and may or may not
have filarial infection.
4000 NCT01547884
TB mHealth Study - Use of Cell
Phones to Improve Compliance in
Patients on LTBI Treatment
This study will examine the impact of use of mobile phones
and text messaging on adherence to treatment for patients
with latent TB infection. Half (50%) of the 350 anticipated
study participants will receive weekly text messages
inquiring on their health status in relation to their prescribed
treatment, while the other half (50%) will not receive weekly
text messages at all. Medical adherence will be assessed by
monthly blood-work, clinic visits and by interviewing
patients at each of these visits.
The investigators hypothesis is that enhanced
communication with a health care provider, via a structured
cell phone SMS text messaging based program (WelTel), will
result in a 15% improvement in the proportion of patients
who successfully complete their LTBI treatment regimens.
Adherance and completion
in treatment
Interventional Phase 0 Allocation:
Randomized
Intervention Model: Single Group
Assignment
Masking: Open Label
Primary Purpose: Health Services
Research
Other: Cell phone text messages
Participants in the intervention
arm will receive weekly text
messages from the TB control clinic
asking how they are.
Canada Sponsor:
University of British Columbia
Collaborator:
British Columbia Cancer AgencyInclusion Criteria:
Are initiating treatment for
latent TB infection350 NCT01549457
Evaluating the Safety and
Effectiveness of Short-Course
Rifapentine/Isoniazid for the
Prevention of Active Tuberculosis in
HIV-Infected Individuals With Latent
Tuberculosis Infection
HIV-infected people have an increased risk of developing
active tuberculosis (TB). The standard course of treatment
for TB is 6 to 9 months of isoniazid (INH). A shorter course of
treatment may be as effective and potentially increase
treatment adherence. This study will compare the safety and
effectiveness of a 4-week regimen of rifapentine (RPT) plus
INH versus a standard 9-month regimen of INH in HIV-
infected people who are at risk of developing active TB.
Treatment/intervention Interventional Phase 3 Allocation:
Randomized, Intervention
Model: Parallel Assignment,
Masking: Open Label, Primary
Purpose: Prevention
Dietary Supplement: Pyridoxine
(Vitamin B6)
Drug: Isoniazid (INH)
Drug: Rifapentine (RPT)
United States, Botswana,
Brazil, Haiti, Kenya,
Malawi, Peru, South
Africa, Thailand,
Zimbabwe
Sponsor:
National Institute of Allergy and
Infectious Diseases (NIAID) HIV + persons with latent TB 3000 NCT01404312
Training Protocol on the Natural
History of Tuberculosis
To provide better training for infectious disease staff
members at the National Institutes of Health Clinical Center
in Washington, D.C., researchers are interested in actively
recruiting individuals with TB for research and treatment
studies. Objectives:
•To provide staff at the National Institutes of Health Clinical
Center with increased experience in hands-on treatment of
individuals with tuberculosis, including drug-sensitive or
drug-resistant forms of the disease.
•To collect blood and other samples to study the natural
history of tuberculosis.
Programme management
Observational
Time Perspective: Prospective United States Sponsor:
National Institute of Allergy and
Infectious Diseases (NIAID)
150 NCT01212003
Prospective Study of
Mycobacterium Tuberculosis
Specific Cellular immune Responses
in Iatrogenically Immunosuppressed
Patients: those undergoing TNF-
alpha blockade or Awaiting Renal
Trasnplants: A Potential New
Method For Accurate Diagnosis of
Latent Tuberculosis Infection in
Clinical Practice
To validate the use of the RD1 based Exvivo IFNy ELISpot in
the immunodiagnosis of tuberculosis in iatrogenically
immunosuppressed populations by calculation of positive
and negative predictive values for the assay and for a
comparator: the tuberculin based mantoux test.
To investigate potential immune correlates of latency and
active disease in tuberculosis and identify potential markers
of prognosis and disease progression in tuberculosis.
Development of new tests
with improved performance
and biomarkers
Observational The RD1 based ex vivo enzyme
linked immunospot assay versus
Tuberculin PPD RT 23 SSI for
mantoux testing
UK-multicentre Sponsor: University of Oxford
Renal failure and iatrogenic
immunosuppression associated
with solid organ
transplantation or TNF alpha
blockade in rheumatoid
arthritis
EudraCT Number: 2005-
005664-88
The V-QUIN MDR TRIAL: A
randomized controlled trial of six
months of daily levofloxacin for
the prevention of tuberculosis
among household contacts of
patients with multi-drug resistant
tuberculosis
To assess the efficacy of preventive therapy (levofloxacin
versus placebo) in all contacts (adults and children)
Treatment/intervention/M
DR
Interventional
Randomised controlled trial
Parallel
Six months of daily oral
levofloxacin
Vietnam NHMRC, Vietnam National
Treatment Program
Household contacts (adults,
adolescents, and children
down to 3 kg) of individuals
with MDR-TB
2006 ACTRN126000215426
TB-CHAMP
To assess the efficacy of
levofloxacin in the prevention of
MDR-TB in child and adolescent
household contacts of MDR-TB
cases.
The lack of evidence on MDR-TB preventive therapy
makes it difficult to develop evidence-based guidelines,
leading to 'recommendations' based on opinion only. If
proven to be efficacious, safe, cost-effective, and
acceptable to families and the NTP, we anticipate that this
trial will inform global guidelines for post-exposure
preventive therapy in child and adolescent contacts of
MDR-TB.
Treatment/intervention Interventional Multi centre phase III, double
blind RCT
24 weeks of daily levofloxacin
against 24 weeks of daily placebo
South Africa Joint Global Health Trials Scheme of
the Department for International
Development (UK), Wellcome Trust,
Medical Research Council, South
African Medical Research Council
Child <5 years who is
household contact of an
enrolled adult MDR-TB case
1556 ISRCTN92634082
Prospective Comparison of the
Tuberculin Skin Test and
Interferon-Gamma Release Assays
in Diagnosing Infection With
Mycobacterium Tuberculosis and
in Predicting Progression to
Tuberculosis
This is a prospective cohort study of persons tested for
latent tuberculosis infection at either high risk for
exposure to Mycobacterium tuberculosis or high risk for
progression to tuberculosis disease. The study will assess
the relative performance and cost of three diagnostic tests
for latent tuberculosis infection (tuberculin skin test,
QuantiFERON-TB Gold In-Tube, and T-SPOT.TB) and will
examine the rates of positive results among the cohort.
This study will also determine the risk and rate of
progression to active TB disease, overall and by the
results of the three tests.
Performance of comercially
available immunotests
Observational Observational Model: Cohort
Time Perspective: Prospective
not provided 10 sites across the
United States
Tuberculosis Epidemiologic Studies
Consortium II (TBESC II)
High risk individuals for
latent TB, including children
and immunocompromised
persons.42647 NCT01622140
Randomized Clinical Trial
Comparing 4RIF vs. 9INH for LTBI
Treatment-effectiveness
The current standard regimen is 9 months of Isoniazid
(9INH). This regimen has excellent efficacy if taken
regularly, but its effectiveness is substantially reduced by
poor compliance. Based on some evidence in treatment of
LTBI, and extrapolating from extensive experience with
treatment of active TB, it is believed that 4RIF has similar
efficacy as 9INH. Therefore, the investigators are
initiating the first multi-site international randomized
trial that will compare the effectiveness of 4RIF and 9INH
in preventing active tuberculosis.
Treatment/intervention Interventional Phase 3 Allocation:
Randomized
Endpoint Classification:
Efficacy Study
Intervention Model: Parallel
Assignment
Masking: Open Label
Primary Purpose: Treatment
Isoniazid versus Rifampin Australia, Benin,
Brazil, Canada, Ghana,
Guinea, Indonesia,
Korea, Republic of,
Saudi Arabia
ponsor:
McGill University
Collaborator:
Canadian Institutes of Health
Research (CIHR) Principal
Investigator: Dr. Dick Menzies5720 NCT00931736
A Randomized Trial to Compare
Effectiveness of 4 Months
Rifampin (4 RIF) With 9 Months
Isoniazid (9 INH) in the
Prevention of Active TB in
Children: The P4v9 Trial
Once children are exposed and infected they are at very
high risk to develop active TB - which can be lethal if not
detected and treated promptly. This makes it very
important to detect TB infection as soon as possible, and
treat this while it is still latent or dormant. Current
therapy for latent TB infection is 9 months of Isoniazid;
this is very effective if taken properly but because
treatment is so long many children do not finish this. Four
months of Rifampin is a recommended alternative. It is
hypothesized that among children at high risk for
development of active TB, intolerance/adverse events will
not be worse (non-inferiority), among those randomized
to 4RIF compared to those randomized to 9INH. In
addition completion of latent tuberculosis infection
(LTBI) therapy will be significantly greater (superiority),
and subsequent rates of active TB will not be significantly
higher (non-inferiority) in children taking 4RIF.
Treatment/intervention Interventional Phase 3
Allocation: Randomized
Endpoint Classification: Safety
Study
Intervention Model: Parallel
Assignment
Masking: Open Label
Primary Purpose: Treatment
Drug: Isoniazid verus Rifampin Australia, Benin,
Brazil, Canada, Ghana,
Guinea, Indonesia
Sponsor:
McGill University
Collaborator:
Canadian Institutes of Health
Research (CIHR)
Information provided by
(Responsible Party):
Dr. Dick Menzies, McGill University
Children (age <18) with
documented positive TST (or
in the absence of TST, a
positive QFT or T-Spot) and
prescribed preventive
treatment for LTBI
822 NCT00170209
Predictive Values of Next
Generation Interferon Gamma
Release Assays for Latent
Tuberculosis Infection
Currently available blood tests for latent tuberculosis
infection (LTBI) identify people who have been previously
infected with M. tuberculosis. Whilst they are sensitive
and specific, they cannot be used to monitor the
effectiveness of treatment for LTBI. New blood tests
("fourth generation Quantiferon tests") have not yet been
evaluated in clinical practice, so their usefulness in
identifying people at highest risk of TB disease and
monitoring treatment is unknown.
Performance of comercially
available immunotests
Interventional Single Group Assignment
Open Label
Primary Purpose: Diagnostic
Procedure: blood test, not yet
marketed, no trade name
blood test using the new TB
diagnostic test
UK Sponsor:
Public Health England
Collaborator:
University College, London
Adult contacts of
smearpositive pulmonary TB
patients and patients with
active TB. Hajj pilgrims:
Individuals arranging travel
to Saudi Arabia for the Hajj
through participating tour
operators.
2000 NCT02512939
Early Detection and Management of
Tuberculosis in the EU.
E-DETECT TB
Establishing a database of latent and active TB in Europe
starting with Italy, Sweden, the Netherlands and the UK to
inform epidemiological analysis and future interventions to
control TB.
Programme management Observational Cohort Latent TB testing and treatment
programmes
Multiple: UK,
Netherlands, Sweden,
Italy, Romania and
Bulgaria
EU Third Health Programme
Chief investigator : Ibrahim Abu bakarVarious https://e-detecttb.eu/
CATAPULT Treatment of latent TB in primary care compared to
secondary care
Programme management Observational A cluster randomised controlled
trial
Treatment of LTBI in primary care UK Barts Charity
Chief investigator: Heinke Kunts
Co-aaplicant: Ibrahim AbubakarMigrants 780 NCT03069807
Prognostic Study of the Interferon
Gamma Release Assay for
Tuberculosis (UK PREDICT TB)
Predictive value of the two commercial IGRAs compared to
TST
Performance of comercially
available immunotests
Observational Cohort Two commercial IGRAs (T-Spot TB
and Quantiferon, TST)
Biobank for substudies
UK Chief investigator: Ibrahim Abubakar
Contacts, Migrants 10,000 NCT01162265
Optimising approaches for LTBI
screening and preventive
treatment. ZonMW
TB ENDPoint
Lessons learned from the different pilots will be used to
improve intervention within the specific target population.
Quantitative results from the pilots on uptake of LTBI
screening and PT will be used as input to assess the long
term impact in terms of costs and cases averted with
different LTBI strategies.
Programme management Observational
Multiple pilot studies Prospective
cohortLTBI intervention
The Netherlands ZonMw (The Netherlands
Organization for Health Research and
Development) – Govt institution.
KNCV, RIVM, Municipal Health
Services, Universities
• Regular immigrants
• Asylum seekers
• Somali and Eritrean
population
http://www.zonmw.nl/nl/p
rojecten/project-detail/tb-
endpoint-tuberculosis-
elimination-in-the-
netherlands-through-
disease-prevention-
optimalization/samenvatti
ng/
Evaluation of contact investigation
in the Netherlands (2006-2013).
Study is based on a previous evaluation report (2016-2010)
with more than 60,000 contacts screened (45,000 for LTBI)
and 3,050 LTBI cases identified.
Programme management ObservationalRetrospective cohort Evaluation
The Netherlands KNCV LTBI cases
>60,000 contacts
screened??
To evaluate the predictive value of
IGRA results from 2008 - 2011 as a
predicitve marker for progression to
tuberculosis.
Assessing predicitive value of IGRA and to understand the
contributing risk factors towards progression of disease.
Performance of comercially
available immunotests
Observational
Retrospective cohort Evaluation
The Netherlands
KNCV LTBI cases 4000 ??
Enhancing the public health impact
of latent tuberculosis (TB) infection
diagnosis and treatment (ACT4)
The trial test a complex intervention- a two phase
programmatic public health package which includes a
standardized public health evaluation and analysis, to
identify problems and barriers limiting LTBI diagnosis and
treatment among close contacts or active TB cases.
Programme management Interventional Allocation: Randomized
Intervention Model: Parallel
Assignment
Masking: Open Label
Primary Purpose: Prevention
LTBI program evaluation &
diagnosis
Benin, Brazil, Canada,
Ghana, Indonesia,
Vietnam
Sponsor: McGill University
Collaborators: Canadian Institutes of
Health Research (CIHR)
LTBI cases among household
contacts of patients with active
pulmonary TB
36 NCT02810678
Promoting adherence to treatment
for latent TB infection through text
messaging
The purpose of this study is to determine whether regularly
scheduled reminder text messages (SMS) are effective in
increasing LTBI treatment completion.
Programme management Interventional Allocation: Randomized
Intervention Model: Parallel
Assignment
Masking: Single Blind
Primary Purpose: Prevention
Regularly scheduled LTBI
medication reminder text
messages
United States
Sponsor: University of Arizona
Collaborators: Pima County Health
Department, American Lung
Association
Adult LTBI cases 250 NCT02690818
Screening latent tuberculosis
infection and observing preventive
therapy in kidney transplantation
Study the prevalence of LTBI in patients who are waiting
renal transplant and monitor the incidence of active TB.
Programme management observational Allocation: Randomized
Endpoint Classification:
Safety/Efficacy Study
Intervention Model: Parallel
Assignment
Masking: Open Label
Primary Purpose: Screening
Screening for LTBI in patients who
are waiting renal transplant and
monitor the incidence of active TB.
Taiwan
Sponsor: National Taiwan University
HospitalRenal transplant patients 800 NCT02782416
Impact of Once-Weekly Rifapentine
and Isoniazid on the Steady State
Pharmacokinetics of Dolutegravir
and Darunavir boosted with
cobicistat in healthy volunteers
The purpose of this study is to determine the effects of
concomitant RPT and INH administration on the steady state
PK of DTG and DRV/c. The use of weekly RPT plus INH is not
currently recommended in adults infected with human
immunodeficiency virus (HIV) on antiretroviral therapy (ART)
due to limited evidence on drug interactions with
antiretrovirals (ARVs). Dolutegravir (DTG) and darunavir
boosted with cobicistat (DRV/c) comprise parts of first-line
Treatment/intervention Interventional Endpoint Classification:
Pharmacokinetics/Dynamics
Study
Intervention Model: Single Group
Assignment
Masking: Open Label
dolutegravir (DTG); rifapentene
(RPT); darunavir/cobicistat (DRV/c);
Isoniazid (INH)
United States National Institutes of Health Clinical
Center
Healthy volunteers 60 NCT02771249
Taima TB: 3HP Study The primary objective of this study is to compare the
proportion of people who complete directly observed
prophylactic treatment (DOPT) using the new 3HP regimen
to the current standard of 9 months INH
Treatment adherance Interventional Phase IV
Intervention Model: Single Group
Assignment
Masking: Open Label
Primary Purpose: Prevention
3 HP Canada Sponsor: Ottawa Hospital Research
Institute
Collaborators: Government of
Nunavut, Government of Canada LTBI diagnosed people (2-65
years) with either TST or IGRA450 NCT02689089
The correlate of risk targeted
intervention study (CORTIS)
A prognostic correlate of risk (COR), based on messenger
ribonucleic acid (mRNA) expression signatures, which
prospectively discriminates between TB cases and healthy
controls, has been constructed and validated. Test whether
preventive therapy (3HP) reduces the rate of incident TB
disease, compared to standard of care (active surveillance),
in COR+ persons.
Test whether COR status differentiates persons with
cumulative prevalent or incident TB disease from persons
without TB disease.
Development of new tests
with improved performance
and biomarkers
Interventional Allocation: Randomized
Endpoint Classification:
Safety/Efficacy Study
Intervention Model: Single Group
Assignment
Masking: Open Label
Primary Purpose: Prevention
Isoniazid, Rifapentine Sponsor: University Cape Town
Collaborators: South African TB
Vaccine Initiative, Aurum Institute,
Centre for the AIDS Programme fo
Research in South Africa, University of
Stellenbosch, London School of
Hygiene and Tropical Medicine, Fred
Hutchinson Cancer Research Center
Aged between 18 and 60, with
known COR and HIV status.3200 NCT02735590
New generation IGRA in
immunocompromised individuals
(Tbnet#54)
Evaluates the performance of a new ELISA based
QuantiFERON-TB plus in-tube test to identify M.tuberculosis
specific immune Responses as evidence of latent infection
with M.tuberculosis in immunosuppressed populations.
Performance of comercially
available immunotests
Observational Observational Model: Cohort
Time Perspective: Prospective
QuantiFERON TB plus in-tube test Germany, Italy, Republic
of Moldova, Norway,
Poland, Portugal,
Romania, Spain, United
Kingdom
Tuberculosis Network European
TrialsgroupImmunocompetent and
immunocompromised patients
with and without risk factors
for prior exposure with M.
tuberculosis
2000 NCT02639936
Testing for Tuberculosis in the
United Kingdom HIV infected
Population
We itend to test a cohort of HIV infected subjects for latent
TB infection in HIV infected individuals to assess the cost-
effectiveness of systematic TB screening and the use anti-TB
antibiotics to prevent reactivation of TB.
Programme management Observational Observational Model: Cohor
Time Perspective: Prospective
IGRA, TST, chest x-ray, sputum, United Kingdom Investigator: Marc Lipman
Sponsor: University College, London
Patients attending an
ambulatory clinic for HIV care
in London, HIV, latent
Tuberculosis
300 NCT02712671
Comparing consistency of
QuantiFERON TB gold plus and
QuantiFERON TB gold for latent
tuberculosis in dialysis population
In patients receiving long term dialysis, using new generation
of QuantiFERON-TB Gold Plus can have less result variability
in inter-experiment and serial follow up in comparing with
QuantiFERON-TB gold in tube.
Performance of comercially
available immunotests
Observational Observational Model: Cohort,
Time Perspective: Prospective
Examination of LTBI by
QuantiFERON TB
Taiwan Chin-Chung Shu
Patients on dialysis 200 NCT02782494
Efficacy of weekly rifapentine and
isoniazid for tuberculosis
prevention
This is an open-label, randomized, Phase III clinical trial to
evaluate the effectiveness and tolerability of the 3RPT/INH
to prevent tuberculosis compared with those who do not
receive preventive treatment among silicotic patients.
Treatment/intervention Interventional Phase 3
Allocation: Randomized
Endpoint Classification:
Safety/Efficacy Study
Intervention Model: Parallel
Assignment
Masking: Open Label
Primary Purpose: Prevention
Weekly INH/RPT given by DOT China Sponsor: Huashan Hospital
Male adult
Silicosis566 NCT02430259
A5300/I2003 PHOENIx Study PHOENIx is a Phase III trial in development by the ACTG
and IMPAACT networks to assess the efficacy of 6
months of daily delamanid (novel intervention arm)
versus 6 months of isoniazid preventive therapy (control
comparison arm) in high -risk household contacts of adult
pulmonary MDR TB cases.
Treatment Interventional Phase 3 efficacy of 6 months of daily
delamanid (novel intervention
arm) versus 6 months of isoniazid
preventive therapy (control
comparison arm) in high -risk
household contacts of adult
pulmonary MDR TB cases
Botswana (1)
Brazil (1)
Haiti (1)
Kenya (1)
India (2)
Peru (2)
South Africa (8)
Tanzania (1)
Thailand (2)
JHU Treating HIV-infected and
other child,
adolescent
and adult household contacts
of MDR TB
patients, including pre
-XDR TB and XDR TB,
who are at high risk of
developing TB.
3,452
A5300/I2003
http://www.impaactnetwo
rk.org/studies/IMPAACT20
03B.asp
Screening for Latent Tuberculosis
Infection (LTBI) in US Army Recruits
(LTBI)
The overall objective of this study is to assess the feasibility
and potential impact of using a targeted testing approach
and 2 interferon-gamma release assays (IGRA) to screen for
latent tuberculosis (TB) infection (LTBI) among military
recruits. The current policy of universal application of the
Mantoux tuberculin skin test (TST) to screen for LTBI may
Programme management observational Intervention Model: Single Group
Assignment
Masking: Double Blind (Subject,
Outcomes Assessor)
Primary Purpose: Screening
Drug: BST
0.1 mcg/mL (1 dose) Battey skin
test (BST) antigen administered
using the Mantoux method.
Drug: TST
Administer TB Skin test (TST)
USA Uniformed Services University of the
Health Sciences
Infectious Diseases Clinical Research
Program
Soldiers 1781 NCT00804713
TB mHealth Study - Use of Cell
Phones to Improve Compliance in
Patients on LTBI Treatment
This study will examine the impact of use of mobile phones
and text messaging on adherence to treatment for patients
with latent TB infection. Half (50%) of the 350 anticipated
study participants will receive weekly text messages
inquiring on their health status in relation to their prescribed
treatment, while the other half (50%) will not receive weekly
text messages at all. Medical adherence will be assessed by
Treatment adherence Interventional Study Type: Interventional
Study Design: Allocation:
Randomized
Intervention Model: Single Group
Assignment
Masking: Open Label
Primary Purpose: Health Services
Cell phone intervention arm:
Upon consent, participants will be
randomly assigned to receive
either 1) standard of care (9
months of INH or 4 months of RIF)
and weekly SMS text messages via
mobile phone or 2) standard of
Canada University of British Columbia
British Columbia Cancer Agency Persons initiating treatment for
latent TB infection over the age
of 18 years old, owning a
mobile phone or share access
mobile phone access AND
demonstrate sufficient ability
350 NCT01549457
MTBVAC Study in Adults With and
Without Latent Tuberculosis
Infection in South Africa (A-050)
MTBVAC at four dose levels: 5 x 10^3 CFU, 5 x 10^4 CFU, 5 x
10^5 CFU, and 5 x 10^6 CFU. The active control is BCG (5 x
10^5 CFU). Participants will receive a single dose of MTBVAC
or BCG revaccination administered intradermally on Study
Day 0.
Vaccination Interventional Phase 1b/2a, double-blind,
randomized, BCG-controlled,
dose-escalation safety and
immunogenicity study.
Participants meeting the
inclusion/exclusion criteria will be
randomized within a study cohort
to receive a single dose of MTBVAC
or BCG revaccination administered
intradermally on Study Day 0.
TParticipants will be randomized
within each cohort, to receive
either MTBVAC (N=96) or BCG
South Africa Aeras
Biofabri, S.L
Universidad de Zaragoza
South African Tuberculosis Vaccine
Initiative
TuBerculosis Vaccine Initiative
Persons of both sexes 18-50
years old, ho have recieved a
prebious BCG vaccination. IGRA
positive or negative.
120 NCT02933281
The Role of IGRA in Screening and
Monitoring for TB During Anti TNF
Therapy in Patients With IMID
(IGRA)
This study aims to investigate the role of IGRA in screening
for latent TB in IBD patients and control subjects. In part II of
the study, patients of other immune-mediated inflammatory
diseases (IMID) will also be included to investigate the role
of serial interferon-gamma release assays (IGRA) for the
diagnosis of tuberculosis (TB) infection in patients with
immune-mediated inflammatory diseases (IMID) treated
with biologics.
Programme management Observational
Observational Model: Case
Control. Time Perspective:
Prospective
Part I of this study aims to
investigate the role of IGRA in
screening for latent TB in IBD
patients and control subjects. Part
II of this study is a prospective
study of serial interferon-gamma
release assays (IGRA) for the
diagnosis of tuberculosis (TB)
infection in patients with immune-
mediated inflammatory diseases
Hong Kong Chinese University of Hong Kong
Patients aged 18 years or
older
patients with a diagnosis of
Crohn's disease (CD) or
ulcerative colitis (UC) for at
least 3 months defined by
histology or radiology
560 NCT02135289
Performance of IGRAs for TB
Infection Diagnosis in Elderly
(IGRage)
TB-infection diagnosis based on immunological memory detection
can be impaired with age. New blood tests (QFTB-G and T-SPOT.TB)
specific for MTB infection have not been evaluated in those old
patients.The primary endpoint of this study is the evaluation of
the IGRAS for active TB diagnosis in patients above 75 years old.The
aim of this study is to evaluate characteristics of the two
commercials tests IGRA T-spot-TB® and Quantiferon-TB-gold- in
tube® and TST in old patients with or without active Tuberculosis.
Performance of comercially
available immunotests
Observational Observational Model: Case-
only. Time
Perspective: Prospective
Diagnostic test performance study;
3 tests performance for active TB
diagnosis in patients older than 75
years-old. Concordance between
IGRAs. Non-concordant results
analysis concordance of IGRAs
results with time of TB-infection
biobank
Paris, France Assistance Publique - Hôpitaux de
Paris
Persons aged > 75 years, birth
before 1935, with suspected Tb
disease.
160 NCT01895582
Primary Prophylaxis for Prevention
of TB in Prison's Populations
To determine if isoniazid is effective in the prevention of tuberculosis in a prison population, exposed to the high endemicity
of the disease.
Treatment Interventional Randomized
Intervention Model: Parallel AssignmentEach subject in the treatment
group will receive two oral
supervised weekly doses of
isoniazid 900 milligram for 52
weeks.
Dourados, Brazil Federal University of Mato Grosso do
Sul
Inclusion Criteria:Minimum
stay estimated at 24 months
under a closed regime, without
active tuberculosis or previous
use of rifapentine or isoniazid,
without consuming alcohol at
least 3 months
728 NCT03028129
IGRA and Mantoux Response in
Children With Suspected Latent or
Active TB Infection (TBTubercolar)
The aim of this project is to analyze the potential
contribution of IGRA test QuantiFERON-TB Gold In Tube test
(QTF-GIT, Cellestis Limited, Carnegie, Victoria, Australia) in
the diagnosis of tuberculosis (TB - active or latent) in
pediatric subjects (0 and 17 year)s recently exposed to
infection (indicated as "contacts") or with clinical suspicion
of active TB, and to compare the results obtained with those
of the TuberculinSkin Test (TST; gold standard).
Performance of comercially
available immunotests
Observational Observational Model: Case-Only Primary Outcome Measures:
Number of patients with
concordance of QTF-GIT test and
TST,among children exposed to TB
[ Time Frame: up to 4 years ]
Number of patients with
positivity of QTF-GIT in comparison
with TST among children with
active tuberculosis disease [ Time
Frame: up to 4 years ]
Number of patients with a
negative QTF-GIT test in
comparison of TST, among non-
infected children [ Time Frame: up
to 4 years ]
Siena, Italy University of Siena Children and young adults
between 0 to 17 years
Contact with TB case and/or
clinical suspect of active TB
50 NCT02653404
Diagnosis of Tuberculosis in Swiss
Children (CITRUS)
The primary objective is to improve the sensitivity of novel
immunodiagnostic tests for detection of TB disease in
children.The secondary objective is to determine biomarkers
that discriminate children with TB infection and disease.
Development of new tests
with improved performance
and biomarkers
Observational Observational Model: Cohort
Time Perspective: Prospective
Secreted cytokine assay for
persons with LTBI, exposure to
active Tb or with active TB.
Cytokines will be measured using a
bead-based multiplex assay reader
(MAGPIX, Luminex Crop., Austin,
USA).
Basel, Bern, Lausanne
Zurich, Switzerland.
University Children's Hospital Basel Children / adolescents < 18
years of age undergoing
evaluation for TB exposure,
infection or disease. No healthy
individuals included.
190 NCT03044509
Evaluation of PET/MRI Using a
Somatostatin Analog Tracer as a
Novel Approach to Detecting
Pathology in High Risk TB-exposed
Contacts
PET/MRI (positron emission tomography/magnetic
resonance imaging) with somatostatin analog tracers has the
potential to provide an imaging technique targeting
subclinical granulomatous disease in those with latent
tuberculosis (TB), allowing identification of individuals who may be
at risk of progression to active TB.
Development of new tests
with improved performance
and biomarkers
Interventional Intervention Model: Single
Group Assignment
Radiation with either an FDG ligand
(other Name: 18F-Fludeoxyglucose)
or with
DOTANOC ligand (other Name:
68Ga-DOTANOC) will beperformed
and standard uptake values (SUV)
Singapore National University Hospital,
Singapore
21 Years and older (Adult,
Senior) with TB exposure, LTBI
or active TB.
30 NCT02967666
The Correlate of Risk Targeted
Intervention Study (CORTIS)
Effective tuberculosis (TB) control requires that people who
progress from latent Mycobacterium tuberculosis (MTB)
infection (LTBI) to TB disease are identified and treated
before they infect others. A prognostic correlate of risk
(COR), based on messenger ribonucleic acid (mRNA)
expression signatures, which prospectively discriminates
between TB cases and healthy controls, has been
constructed and validated. Based on published microarray
case-control datasets, the COR has 87% diagnostic sensitivity
Development of new tests
with improved performance
and biomarkers
Observational Randomized
Intervention Model: Single Group
Assignment
Drug: Isoniazid: Participants in the
Treatment Arm will receive high
dose Isoniazid - 15mg per kg body
weight, rounded up to the nearest
100 mg; maximum dose 900 mg
with Pyridoxine supplementation
(25mg) and Rifapentine based on
body weight (>32kg - 50kg: 750 mg;
>50kg: 900 mg), given weekly as 12
Cape town, SA Sponsor:
University of Cape Town
Collaborators:
South African Tuberculosis Vaccine
Initiative
Aurum Institute
Centre for the AIDS Programme of
Research in South Africa
University of Stellenbosch
Ages Eligible for Study 18 Years
to 60 Years (Adult), all sexes,
healthy Volunteers accepted.
3200 NCT02735590
MVA85A Aerosol vs Intramuscular
Vaccination in Adults With Latent
Mycobacterium Tuberculosis (M.
tb) Infection
A Phase I Trial to Compare the Safety and Immunogenicity of
Candidate TB Vaccine MVA85A Administered by the Aerosol
Inhaled Route and the Intramuscular Route in Healthy Adult
Volunteers Who Are Latently Infected With Mycobacterium Tuberculosis
Vaccine Interventional Allocation: Randomized
Intervention Model: Parallel
Assignment
Masking: Participant, Care
Provider, Investigator, Outcomes
Assessor
Primary Purpose: Other
Biological: Aerosol inhaled
MVA85A or
intramuscular MVA85A or
intramuscular Saline placebo or
aerosol inhaled Saline placebo
UK University of Oxford
Study Director: Helen McShane
University of Oxford
Principal Investigator: Paul Moss
University of Birmingham
Principal Investigator: Marc Lipman
Royal Free Hostpital
Principal Investigator: Felicity Perrin
King's College Hospital NHS Trust
Ages Eligible for Study: 18
Years to 55 Years (Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers:
Yes
15 NCT02532036
ENhance Initiation and Retention in
Isoniazid Preventive Therapy (IPT)
Care for HIV Study (ENRICH Study)
(ENRICH)
To evaluate a combination intervention package (CIP)
designed to improve implementation of Isoniazid Preventive
Therapy (IPT) among people living with HIV (PLWH) in
Ethiopia.
Programme management Interventional Allocation: Randomized
Intervention Model: Parallel
Assignment. The study is a two-
arm cluster randomized trial,
randomized at the HIV clinic
level, which includes 10 HIV
clinics in Dire Dawa and Harari,
Ethiopia. Clinics are randomized
to deliver the combination
intervention package (CIP) or
standard of care (SOC), with
stratification by facility size (<80
or >80 patients enrolled in HIV
care per year)
Behavioral: Combination
intervention components
Drug: Isoniazid Prevention Therapy
The experimental intervention will
be delivered to all patients in HIV
clinics randomly assigned to CIP
who initiated HIV care at the CIP
site on or after January 1, 2013 and
initiated IPT on or after date of
study initiation, July 1, 2013. In HIV
clinics assigned to SOC, usual care
procedures for provision of IPT will
be delivered.
Ethiopia Sponsor:
Columbia University
Collaborator:
National Institute of Allergy and
Infectious Diseases (NIAID)
Sexes Eligible for Study: 338
NCT01926379
Latent Tuberculosis Infection in
Korean Health Care Workers Using
Interferon Gamma Releasing Assay
To determine the proportion of Korean Health Care worker
using the IGRA
Programme management Observational Single Group Assignment, Masking:
Open Label, Primary Purpose:
Screening
QFT-IT Test and other blood sampling Korea, Republic of Hanyang University, Korea, Republic of
- Health care workers in University
affiliated hospital
- Adult aged 20-65
240 NCT03010111
Rifampin versus isoniazid for the
treatment of latent tuberculosis
infection: Part 3 effectiveness
A randomised clinical trial comparing 4 months of rifampin to 9
months of isoniazid for the treatment of latent tuberculosis
infection: To compare the cumulative incidence during 28 months
after randomisation, of confirmed active tuberculosis (TB) among
all persons randomised (effectiveness, using intention to treat
analysis) to 4RIF and 9INH
Treatment/intervention
Interventional Multicentre randomised two-arm
positive controlled open-labelled
clinical trial (Treatment)
Rifampin (drug) and isoniazid (drug).
The dosage of the medication is
determined according to the weight of
the subject:
Isoniazid: once per day, in pill format,
for a total daily dose of 300 mg if
subject weighs greater than or equal
to 42 kg, otherwise 200 mg. Total
Australia Benin Brazil
Canada Ghana Guinea
Indonesia Korea, South
Saudi Arabia
The Research Institute of the McGill
University Health Centre (Canada)
Adults (aged greater than 18
years, either sex) with
documented positive tuberculin
skin test (TST) and prescribed
9INH for LTBI, following
authoritative recommendations.
Ecluding amongst others PLHIV.
5720 ISRCTN05675547
Correlation of the Precursor
Frequency of CD4 + Effector
Memory T Cells With Induration
Measured in the Tuberculin Skin
Test (TST)
The purpose of the present study is to evaluate the latent form of
this infection, the prevalence of which worldwide exceeds that of
active disease. Our hypothesis is that in latent tuberculosis antigen
specific effector memory CD4+ T cells are responsible for the
generation of clinically measurable delayed type hypersensitivity
and that central memory CD4+T cells are not directly involved in
this process. We base this idea on the assumption that latent
tuberculosis is a state of antigen persistence and that effector
memory T cells should be maintained as long as antigen/infection
is present.
Other (immunology,
pathogenesis, co-infection)
Observational NP NP Mali, West Africa
Persons18 Years and older
(Adult, Senior), both sexes32 NCT00257907
A Phase I Trial to Compare the
Safety and Immunogenicity of
Candidate TB Vaccine MVA85A
Administered by the Aerosol
Inhaled Route and the
Intramuscular Route in Healthy
Adult Volunteers Who Are Latently
Infected With Mycobacterium
Tuberculosis
TB040 is a clinical trial to investigate and compare the effects of a
candidate Tuberculosis (TB) vaccine, MVA85A, administered by
the aerosol inhaled route and the intramuscular route in healthy
adult volunteers who are latently infected with Mycobacterium
tuberculosis.Treatment/intervention
Interventional
Allocation: Randomized
Endpoint Classification: Safety
Study
Intervention Model: Parallel
Assignment
Masking: Double Blind (Subject,
Caregiver, Investigator,
Outcomes Assessor)
•Biological: Aerosol inhaled
MVA85A
Other Name: MVA85A
•Biological: Intramuscular
MVA85A
Other Name: MVA85A
•Biological: Intramuscular Saline
placebo
UK
Sponsor:
University of Oxford
Collaborator:
University of Birmingham
30
NCT02532036
The HALT-LTBI study: Phase IV,
multi-site, unblinded, randomised
trial of prophylactic daily
rifampicin/isoniazid vs. weekly
rifapentine/isoniazid for latent
tuberculosis infection (LTBI)
To assess completion rates of two different LTBI treatment
regimens (daily rifampicin/isoniazid, the current UK standard
treatment, vs weekly rifapentine/isoniazid). The objective of the
pilot phase would be to assess feasibility and safety.
Treatment/intervention Interventional Unblinded RCT Random allocation to either Rifinah
(Rifampicin plus Isoniazid) or
Rifapentine and Isonazid.
UK-multicentre Sponsor: University College London
Latent tuberculosis infection 100 ISRCTN04379941
Developing a partnership to inform UK-Brazil TB control: Investigating the efficacy of BCG vaccination following latent tuberculosis treatment.To evaluate the effect of BCG vaccination after treatment of latent TB infectionTreatment/intervention Interventional Pilot trial BCG vaccine after treatment of LTBI, serial IGRA BrazilMRC Principle investigator (UK): Ibrahim Abubakar, Brazil (Sergio Arruda) ??
Next Generation Tests for Latent Tuberculosis and Predicting Active Tuberculosis.Prognostic value of the next generation quantiferon test and biomarkers for progressionDevelopment of new tests with improved performance and biomarkers Observational Cohort IGRA (4th Gen)Biobank for substudies UK Multi-CentreNIHR,University College London Chief investigator: Ibrahim AbubakarAdult contacts of pulmonary TB 2000 ??
Effectiveness Of Testing For And Treatment Of Hard-To-Reach Groups For Latent Tuberculosis, Hepatitis B Virus And Hepatitis C Virus In England.The impact and value for money of peer support to improve clinical engagement inhard-to-reach individuals with hepatitis C virus (HCV) will be assessed.Assessment of completion rates for a novel, short, LTBI treatment regimen.Adherance and completion in treatment Observational Cohort IGRA tests UKFunder: UK Department of HealthSponsor: Public Health England Principle investigator: Ibrahim AbubakarContacts, Migrants and others at risk of LTBI ??
Programme grant to control tuberculosis among hard to reach patients in London. (includes an LTBI survey in prisons and injecting drug users)Assess prevalence of latent TB in hard to reach groups Programme management Observational Cross sectional study IGRA UK Funder: NIHRChief Investigator: Andrew Hayward Hard to reach groups ??
Impact, acceptability and cost-effectiveness of identifying infectious diseases amongst migrants in primary care (this includes latent TB screening).Assess prevalence of latent TB in migrants Programme management Observational Cohort IGRA UK Chief Investigator: Manish Pareek Migrants ??
Latent Tuberculosis Infection (LTBI) among migrant workers from third countries in CyprusScreening for latent TB infection in migrants using IGRA and analysis of progression to disease following 6 months IPT.Programme management Observational Prospective cohort LTBI intervention Cyprus Sponsor: Under negotiationCenter for Communicable Disease Control, Makarios III Hospital, Nicosia Pulmonology Clinic, Nicosia General Hosp.University of NicosiaMigrant workers 1000 To be announced
To assess targeting of LTBI treatment in Norway (2008 to 2014)The purpose of the study is to explore risk factors for TB in Norway and assess the targeting of LTBI screening and treatment 2008-2014. The population includes all persons tested with IGRA OR who has been notified to the Norwegian TB register with TB or LTBI treatment in Norway in 2008-2014. These data will be linked to Statistics Norway for demographic data, Norwegian prescription database for prescriptions and the Norwegian Hospital Discharge Database for co-morbidities. Programme management Observational Register-based study Norway Norwegian Health Association (NHA)All cases with an IGRA result (positive and negative) OR TB or LTBI treatment80000 ??
Assess outcome of LTBI treatment
and reasons for non-completion.
Data will include all cases prescribed with LTBI treatment in
Norway in 2016. The data to be collected are to a large extent
consistent with the LTBI Task force suggestions for monitoring and
evaluation, with more detailed data on safety. We will use this as a
pilot for assess the feasibility of routine monitoring of LTBI
treatment outcome.
Programme management Observational Prospective cohort Norway Norwegian Institute of Public Health
(NIPH)
LTBI cases
App 700
Information will soon be
available on the web
Barriers to TB screeningThis is a qualitative study among immigrants run by an NGO (LHL international) aiming to identify barriers to screening for TB.Programme management Observational Qualitative study Norway Norwegian Heart and Lung Association (LHL International) Immigrants 25 ??
Evaluation of LTBI screening policy in the National TB Control Plan (2016-2020).National data collection and analysis of LTBI screening policy, practices and results of clinical risk groups in hospitals, as part of the National TB Control Plan 2016-2020.Programme management Evaluation Prospective Observational The Netherlands KNCV LTBI cases The National TB Control Plan will be published soon (in Dutch) and sent out for translation.
Evaluation of LTBI screeing and
prevention among at risk migrant
populations
Programme management observational Evaluation
The Netherlands KNCV ??
US NIH clinical centre trial
NCT02777229
Impact of 3HP on the steady state pharmacokinetics of
Dolutegravir and Darunavir boosted with Cobicistat in
Healthy Volunteers
Treatment Interventional
NCT02777229
ViiV Healthcare clinical trial[1] (Phase III-
b study)
Concomitant treatment with EFV-based ARV and RIF-containing TB therapy is
demonstrated to be safe and effective however side-effect profile of EFV
overlaps with the rifampicin. This trial is designed to study safety and efficacy of
Dolutegravir or Efavirenz administered with two NRTIs in HIV-1-infected ART-
naïve adults starting WHO-recommended standard treatment for rifampicin-
sensitive TB
Treatment Interventional
NCT02178592
ADVANCE[2] is a USAID funded and Wits Reproductive Health and HIV Institute led trialSupport studies planned with this trial likely to generate more evidence of RIF/DTG and RIF/TAF interactions by September 2019Treatment Interventional
French National Institute for Health
and Medical Research trial in
Cameroon[3] (phase III randomized
controlled trial)
A sub-study as a part of this trial is planned to review the pharmacokinetics of
DTG and EFV 400 use in TB co-infected patients
Treatment Interventional
Improving the Detection of Active
Tuberculosis in Accident and
Emergency Departments (ACE)
This proposal is focused upon early diagnosis, referral
and treatment of active tuberculosis, which has two key
components: 1) ensuring optimal outcome for individuals;
2) contributing to disease control in public health terms
by preventing further spread.
Operational &
programmatic
Observational Prospective cohort Procedure: venepuncture,
sputum collection, xray
venepuncture, sputum collection,
xray
UK Sponsor: Public Health England
Principle investigator: Ibrahim
Abubakar
Individuals at high risk of TB 1000 NCT02512484
3 HP pharmacokinetics when given
with dolutegravir or efavirenz
Pharmacokinetics Interventional 3 HP selfadministered therapy,
single course or on a yearly basis in
high TB burden settings http://www.tbonline.info/me
dia/uploads/documents/tb_c
ab_meeting_report_decembe
r2015_capetown_external_fi
nal.pdf
ACTG 5279: Phase III Clinical Trial of
Ultra-Short-Course
Rifapentine/Isoniazid for the
Prevention
To compare two treatments to prevent active TB in persons with HIV and latent TB Treatment Interventional Randomised. Controlled phase IIIRifapentine, Isoniazid and vitamin B6 (pyridoxine) will be provided while on study. Subjects will take Rifapentine/Isoniazid plus B6 for 4 weeks or Isoniazid plus vitamin B6 for 9 monthsJHU For People who have HIV and Latent Tuberculosis
TBTC Study 37: Shortened RPT regimen for PT Treatment Interventional Randomized, controlled RPT qd for 6 wks vs. RIF qd 4 mo vs. RPT+INH qwk
TBTC Study. An Evaluation of
Adherence to Latent Tuberculosis
Infection (LTBI) Treatment With
12 Doses of Once Weekly
Rifapentine (RPT) and Isoniazid
(INH) Given as Self-administered
(SAT) Versus Directly-observed
Therapy (DOT): iAdhere.
The trial is conducted in patients diagnosed with latent
tuberculosis infection (LTBI) who are recommended for
treatment. The primary objective is to evaluate adherence
to a three-month (12-dose) regimen of weekly rifapentine
and isoniazid (3RPT/INH) given by directly observed
therapy (DOT) compared to self-administered therapy
(SAT).
Operational/treatment
adherance
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification:
Safety/Efficacy Study
Intervention Model: Parallel
Assignment
Masking: Open Label
Primary Purpose: Prevention
•Behavioral: Self Administered
Therapy (SAT)
Self Administered Therapy (SAT)
•Behavioral: SMS reminders
Short Message Service (SMS) text
reminders
•Drug: isoniazid and rifapentine
United States, China,
South Africa, Spain
Sponsor:
Centers for Disease Control and
Prevention
1) persons with a positive
TSTor IGRA AND one of the
following: close contact to
someone with culture
confirmed TB, HIV infection,
or > 2 cm2 of pulmonary
parenchymal fibrosis on chest
X-ray and no prior history of
TB treatment; 2) TST or IGRA
converters 3) Persons with
any other clinical indication
for LTBI treatment (e.g. HIV-
infected close contacts to an
active pulmonary TB cases)
1002 NCT01582711
Evaluation of LTBI management in
the Netherlands (1993-2013).
Description of LTBI recording and reporting system and the
results of 21 years of LTBI monitoring and evaluation,
focusing on trends in target groups for LTBI screening and
preventive treatment (PT) regimens, including PT initiation,
PT completion and PT discontinuation related to the
occurrence of adverse events are explored.
Operational Observational
Retrospective cohort Evaluation
The Netherlands
KNCV LTBI cases 37,729 ERJ
Risk to develop TB among persons
diagnosed with LTBI in the
Netherland (1993-2013).
Risk to develop TB among persons diagnosed with LTBI in
the Netherlands. This study examines TB incidence among
persons identified with LTBI and determines risk factors
associated with progression to TB among those treated and
untreated.
Risk factors and disease
progression
Observational
Retrospective cohort Evaluation
The Netherlands
KNCV LTBI cases ERJ
Landscaping on on-going
developments for tests that better
predict progression from latent TB
Disease progression and risk
factors
Guideline
development
??
Target Product Profile (TPP): Test
for Progression of Tuberculosis
Infection
Guide test developers as to key requirements for assays to
better predict progression from infection to active disease
Other (immunology,
pathogenesis, co-infection)
Evaluation and
developmental
??
Document to outline trial guideline
to evaluate tests that better predict
progression from latent TB
provide guidance on key study design
requirements when evaluating tests that better
predict progression from infection to active disease
Disease progression and risk
factors
Guideline
development
??
Development of Human Nasal
Challenge Models With Microbial
Constituents and Grass Pollen
The investigators will carry out nasal challenge with bacterial
and viral components and allergens. In this way the nasal
upper respiratory tract mucosa is challenged with stimuli of
the immune system, causing various types of inflammation.
Samples will be taken by blotting the nostril surface and by
scraping off tiny surface samples.
Other (immunology,
pathogenesis, co-infection)
Interventional Non-Randomized The nose will be sprayed with a
substance that is a single part of a
bacteria or virus, or with an
allergen.The study employs
noninvasive methods of sampling
using absorptive strips. These strips
look and feel like tissue paper, and
are applied to each nostril for a
period of 1 min. A few pinhead-
sized tissue samples are taken from
inside the nose, using a small
disposable sterile plastic probe that
has a tiny scoop on its end. In the
nasal lining fluid and tissue
samples, measurement will taken
UK Imperial Clinical Respiratory Research
Unit (ICRRU), St Mary's Hospital
Males and females aged 18 to
60 years. Current non-smokers
for last year, maximum of 10
cigs per month, with a smoking
history of <5 pack years
174 NCT02090374
Impact of New Immunological
Diagnosis Tests of Latent Tuberculosis
Before Anti TNF Therapy
The primary endpoint of this study is the evaluation of the theoric
therapeutic impact of the use of new tests for diagnosis of LTBI in
patients before anti TBF therapy
Diagnostic and screening Interventional Single Group Assignment The primary endpoint of this study is
the evaluation of the theoric
therapeutic impact of the use of new
tests for diagnosis of LTBI in patients
before anti TBF therapyBiological:
QFTB-G and T-SPOT.TB tests
France Assistance Publique - Hôpitaux de Paris
Ages Eligible for Study: 18
Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers:
No 430 NCT00811343
Evaluation of an Enhanced
Tuberculosis Infection Control
Intervention in Healthcare Facilities
in Vietnam and Thailand (EnTIC)
Evaluation of an Enhanced Tuberculosis Infection Control
Intervention in Healthcare Facilities in Vietnam and Thailand.
Prevalence of latent Tuberculosis infection (LTBI) in
healthcare workers (HCWs) will be at measured at baseline,
and LTBI incidence will be measured among susceptible
HCWs at 12 and 24 months. Secondary outcomes will be
measures at 0 (pre-intervention) 6, 12, 18, and 24 months. In
year three, results will be analyzed and disseminate
Infection control Observational Stratified, matched, cluster-
randomized, controlled trial
Facilities randomized to the
intervention group will receive:
Skills-based training addressing the
hierarchy of TB IC measures, how
to conduct a facility TB IC /risk
assessment; and development,
implementation, and monitoring of
an operational TB IC plan for the
facility. Audits and Feedback of
performance A TB IC
Viet Nam and Thailand Centers for Disease Control and
Prevention
United States President's Emergency
Plan for AIDS Relief
Health care worker; this study
will be conducted at 22
hospitals, 10 in Thailand and 12
in Vietnam
? NCT02073240
Surveillance and Follow-up for
Latent Tuberculosis Infection and
Observation of the Effect of
Prophylactic Latent Tuberculosis
Treatment in Patients With Severe
Chronic Kidney Disease or Receiving
Long-term Dialysis
To follow-up latent tuberculosis infection and evaluate the
risk of developing active tuberculosis in patients with severe
chronic kidney disease or receiving long-term dialysis
§ Observational
Observational Model: Cohort
Time Perspective: Prospective Not provided
Taiwan
Sponsor:National Taiwan University
Hospital
The patients with severe
chronic kidney disease or long
term dialysis
500 NCT01685086
Is Tuberculin Skin Testing Effective
in Screening for Latent Tuberculosis
in Patients With HIV?
HIV infection highly increases the risk of progression of
latent tuberculosis (TB) to active disease that therapy is
recommended for all PPD-positive, HIV-infected patients,
regardless of age. Sensitivity of the PPD testing is, however,
dependent on a normal T cell function.
Therefore, an accurate and reliable method for detection of
latent tuberculosis in patients with HIV is urgently needed.
This prospective study will examine the utility of interferon-
Programme management Observational
Observational Model: Case
Control
Time Perspective: Prospective
T-Spot.TB test
United States
Sponsor:
North Shore Long Island Jewish Health
System
Adult patients with HIV
confirmed by standard
methods
53 NCT00763295
Determining Risk in Latent
Tuberculosis
Understanding the risk factors that contribute to latent TB
developing into active TB, and whether it is possible to test
for this risk.
Development of new tests
with improved performance
and biomarkers
Observational Observational perspective Not provided Korea, Republic of Sponsor: National Institute of Allergy
and Infectious Diseases (NIAID)
Healthy particpants not
exposed to TB, active TB, latent
TB,
1200 NCT01571739
Improving Latent Tuberculosis (TB)
Diagnosis in Thai Children
Objective is to assess the sensitivity and specificity of IGRAs
and TST in screening for latent TB HIV-infected and HIV
uninfected children in Thailand, to improve the diagnosis
and management of latent TB.
Performance of comercially
available immunotests
Observational
Observational cohort,
prospective
Not provided Thailand Sponsor: South East Asia Research
Collaboration with Hawaii
Collaborators:
•Columbia University
•New York Blood Center
•HIV Netherlands Australia Thailand
Research Collaboration
•Queen Sirikit National Institute of
Child Health
Thai children between the ages
of 2 months and 16 years with
exposure to active TB adult
cases will be referred to the
two study sites for eligibility
screening.
158 NCT00947609
Comparing the Efficacy of Two
Preventive Regimens for Adult
Household Contacts With Latent
Tuberculosis Infection
Though still an endemic area, the incidence of tuberculosis
(TB) in Taiwan is decreasing in recent years. Further
reduction in TB incidence, or even elimination should rely on
treatment for LTBI. However, which is the cost-effective
screening method or what is the cost-effective regimen in
Taiwan is still unclear.
Therefore, the investigators designed this prospective study
to follow up adult household contacts with LTBI for 2 years
and compare the efficacy of 9-month isoniazid and 4-month
Treatment Interventional
Phase 3, RCT, parallel, open lable,
intervention
4-month rifampin (Experimental)
vs. 9-month isoniazid (Active
comparator)
Taiwan
Sponsor:National Taiwan University
Hospital
Adult household contact of
patients with newly diagnosed,
culture-confirmed pulmonary
tuberculosis
300 NCT01398618
Better Identification of Latent
Tuberculosis Infection Among Israeli
Young Adults by Comparison Skin
Tests and Interferon Gamma
Releasing Assays (IGRA)
The aim of study is to evaluate the prevalence of latent TB in
second generation immigrants from countries with high
incidence of tuberculosis (above 20 of 100,000) compare to
the control native Israelis without a family member who was
born in a country with high incidence of tuberculosis. Using
study questionnaire IGRA and tuberculin skin test the
investigators expect that the second generation immigrants
group will have more positive IGRA test than the control
native group.
Programme management Observational
Non-Randomized, Single Blind
(Investigator), Parallel
Assignment
Answering the study Questionnaire
and blood sampling for Interferon
gamma release assay (IGRA)
Israel Sponsor:
Sheba Medical Center
Collaborator:
Tel Aviv Lung Association
Second generation immigrants
from countries with high
incidence of tuberculosis
(above 20 of 100,000).
Native Israelis
without a family member who
was born in a country with high
incidence of tuberculosis.
200 NCT02073669
Impact of HIV Infection on Latent
TB Among Patients With HIV-TB Co-
infection
HIV induced altered representation and function of
regulatory T cell subsets (NKT and Treg cells) impair the
protective T cell response against M.tuberculosis and
disrupts LTBI, thus facilitates faster progression and
development of severe forms of clinical TB in HIV-TB co-
infection.
Other (immunology,
pathogenesis, co-infection)
Observational
Prospective Not provided
India Sponsor:
Ministry of Science and Technology,
India
Collaborator:
Indian Council of Medical Research
HIV+ve+LTBI HIV+ve+clinical TB
HIV-ve+clinical TB Normal
control
180 NCT00692809
Screening for Latent Tuberculosis in
Healthcare Workers With
Quantiferon-Gold Assay: A Cost-
Effectiveness Analysis
The ministry of health in Israel requires all health-care
workers to undergo screening for latent Tuberculosis
infection (LTBI) prior to starting work. This is based on the
Mantoux skin test, which is notoriously unreliable.
In recent years, more specific and sensitive tests based on
interferon-gamma secretion to TB antigens have come to
market, and most current evidence shows that many
mantoux positive persons do not have LTBI. Quantiferon-
GOLD is one of these assays.
In this prospective study, we will draw blood for the
Quantiferon-GOLD assay in parallel to conventional testing,
and perform a cost-effectiveness analysis of the cost of the
investigation and treatment of LTBI in health-care workers.
Programme management Observational
Defined Population
Screening
Longitudinal
Blood test for Quantiferon-GOLD
assay
Israel
Sponsor: Assuta Hospital Systems
Collaborator: Maccabi
Inclusion Criteria:150 NCT00449345
Prospective Comparison of the
Tuberculin Skin Test and Interferon-
Gamma Release Assays in
Diagnosing Infection With
Mycobacterium Tuberculosis and in
Predicting Progression to
Tuberculosis
This is a prospective cohort study of persons tested for
latent tuberculosis infection at either high risk for exposure
to Mycobacterium tuberculosis or high risk for progression
to tuberculosis disease. The study will assess the relative
performance and cost of three diagnostic tests for latent
tuberculosis infection (tuberculin skin test, QuantiFERON-TB
Gold In-Tube, and T-SPOT.TB) and will examine the rates of
positive results among the cohort. This study will also
determine the risk and rate of progression to active TB
disease, overall and by the results of the three tests.
Performance of comercially
available immunotests
Observational Cohort
Prospective
Not provided USA
Sponsors and Collaborators
Centers for Disease Control and
Prevention
Individuals at high risk for
latent tuberculosis infection or
at high risk for progression to
tuberculosis
42647
NCT01622140
Study of Latent Tuberculosis
Infection (LTBI) by High Resolution
Scanner
The High Resolution Scanners (HR TC) offer the possibility of
detecting any lesion approximately 1 mm in diameter, so the
investigators plan to use this technique to screen people
already infected by M. tuberculosis (but not ill, following the
Diagnosis Standard Guidelines).
Development of new tests
with improved performance
and biomarkers
Observational Case-Only
Prospective
Not provided Spain Sponsor:
Germans Trias i Pujol Hospital
Collaborator:
CIBERES CRP-TB program
Only a single population is
going to be studied: the LTBI,
thus people with proof to be
M. tuberculosis infected but
demonstrating not having
active disease.
12 NCT00904956
The Usefulness of Interferon-γ
Release Assays and Tuberculin Skin
Test for Detection of Latent
Tuberculosis Infection
The purposes of this study
1.to compare the positivity of tuberculin skin test(TST) and
QuantiFERON-TB Gold (QFT-G), and determine the level of
agreement between two tests in patients with rheumatic
diseases
2.to evaluate the difference in the occurrence of active TB in
patients who receive both QFT-G and TST compared with
those who receive only TST for detecting of Latent
tuberculosis infection(LTBI) who are candidates of TNF
inhibitors.
Performance of comercially
available immunotests
Observational
Cohort
RetrospectiveNot provided
Korea, Republic of Sponsor:
Hanyang University
Collaborator:
Bristol-Myers Squibb
•Approximately 2,000 patients
with rheumatic diseases who
examined TST or QFT-G
•Approximately 400 patients
with rheumatic diseases who
received TST or QFT-G before
using anti-TNF agents.
2000 NCT01685905
A Phase I/II Trial of the
Pharmacokinetics, Tolerability, and
Safety of Once-Weekly Rifapentine
and Isoniazid in HIV-1-infected and
HIV-1-uninfected Pregnant and
Postpartum Women With Latent
Tuberculosis Infection
The purpose of this study is to evaluate the
pharmacokinetics, tolerability, and safety of once-weekly
doses of rifapentine (RPT) and isoniazid (INH) in HIV-1-
infected and HIV-1-uninfected pregnant and postpartum
women with latent tuberculosis (TB).
Treatment/pharmacokinetics
Interventional
Non-Randomized,
Pharmacokinetics Study,
Parallel Assignment,
Open Label
•Drug: Rifapentine (RPT)
900 mg of RPT
•Drug: Isoniazid (INH)
900 mg of INH
•Dietary Supplement: Pyridoxine
(vitamin B6)
Not provided Sponsor:
National Institute of Allergy and
Infectious Diseases (NIAID)
This study will enroll HIV-1-
infected and HIV-1-uninfected
pregnant women with latent
TB . Cohort 1 participants will
be enrolled in their second
trimester. Cohort 2
participants will be enrolled in
their third trimester
82 NCT02651259