Download Summary and Purpose Field/research Study type Study design

Summary and Purpose
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
Field/research
Study type
Intervention
Study location
Sponsor, collaborator and investigator
HIV infection highly increases the risk of progression of latent tuberculosis (TB) to active
Diagnostic
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.
Observational
Therefore, an accurate and reliable method for detection of latent tuberculosis in patients
with HIV is urgently needed.
Disease progression and risk
factors
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not provided
Taiwan
Observational Model: Case
Control
Time Perspective: Prospective
T-Spot.TB test
United States
Observational perspective
Not provided
Objective is to assess the sensitivity and specificity of IGRAs and TST in screening for latent TB Diagnostic
HIV-infected and HIV uninfected children in Thailand, to improve the diagnosis and
management of latent TB.
Though still an endemic area, the incidence of tuberculosis (TB) in Taiwan is decreasing in
Treatment
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.
Diagnostic
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 coinfection.
Disease progression and risk
factors
Status
Available source of
information
(website, trial
identity code)
Observational cohort,
prospective
Thailand
Sponsor:National Taiwan University Hospital
The patients with severe chronic
kidney disease or long term dialysis
500
Recruiting
NCT01685086
Sponsor:
North Shore Long Island Jewish Health System
Adult patients with HIV confirmed by
standard methods
53
Reruitment completed
NCT00763295
Healthy particpants not exposed to
TB, active TB, latent TB,
1200
Terminated
NCT01571739
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
Completed
NCT00947609
Adult household contact of patients
with newly diagnosed, cultureconfirmed pulmonary tuberculosis
300
nown status, not recru
NCT01398618
200
Not yet recruiting
NCT02073669
180
Recruiting
Sponsor: National Institute of Allergy and Infectious
Diseases (NIAID)
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
Interventional
Intervention
Phase 3, RCT, parallel, open
lable, intervention
Non-Randomized, Single Blind
(Investigator), Parallel
Assignment
Taiwan
Answering the study Questionnaire and blood
sampling for Interferon gamma release assay
(IGRA)
Sponsor:National Taiwan University Hospital
Sponsor:
Sheba Medical Center
Israel
Collaborator:
Tel Aviv Lung Association
Observational
Prospective
Not provided
India
Ministry of Science and Technology, India
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.
Observational
This is a prospective cohort study of persons tested for latent tuberculosis infection at either Diagnostic and disease
high risk for exposure to Mycobacterium tuberculosis or high risk for progression to
progression
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.
HIV+ve+LTBI HIV+ve+clinical TB HIVve+clinical TB Normal control
NCT00692809
Indian Council of Medical Research
Operational
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.
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.
Sponsor:
Collaborator:
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).
Sample size
4-month rifampin (Experimental) vs. 9-month
isoniazid (Active comparator)
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
rifampicin).
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.
Korea, Republic of
Not provided
Observational
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.
Study population/condition
Disease progression and risk
factors
Observational
This prospective study will examine the utility of interferon-gamma (IFN-γ) based assay, TSPOT TB for detection of TB in HIV infected individuals
Understanding the risk factors that contribute to latent TB developing into active TB, and
whether it is possible to test for this risk.
Study design
Defined Population
Screening
Longitudinal
Cohort
Prospective
Blood test for Quantiferon-GOLD assay
Israel
Sponsor: Assuta Hospital Systems
USA
Sponsors and Collaborators
Centers for Disease Control and Prevention
Case-Only
Prospective
Observational
150
Recruiting
42647
Recruiting
NCT00449345
Not provided
Observational
Diagnostic
Inclusion Criteria:
Collaborator: Maccabi
Not provided
Sponsor:
Germans Trias i Pujol Hospital
Spain
Collaborator:
CIBERES CRP-TB program
Individuals at high risk for latent
tuberculosis infection or at high risk
for progression to tuberculosis
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.
NCT01622140
12
Recruiting
NCT00904956
Information from TF members
The purposes of this study
Diagnostic
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 QFTG and TST compared with those who receive only TST for detecting of Latent tuberculosis
infection(LTBI) who are candidates of TNF inhibitors.
Sponsor:
Hanyang University
Observational
The purpose of this study is to evaluate the pharmacokinetics, tolerability, and safety of once- Treatment/intervention
weekly doses of rifapentine (RPT) and isoniazid (INH) in HIV-1-infected and HIV-1-uninfected
pregnant and postpartum women with latent tuberculosis (TB).
Cohort
Retrospective
Non-Randomized,
Pharmacokinetics Study,
Parallel Assignment,
Open Label
To compare the effectiveness of linking the Quantiferon-gold in-tube test (QGIT) with routine Diagnostic
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 costeffectiveness of linking QGIT with routine CD4 compared to routine TST will also be
evaluated,
Interventional
Interventional
Interventional
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.
Diagnostic and disease
progression
The apoptosis-associated markers, including Fas ligand, Decoy-receptor 3, Lipoxin, and
Biomarkers and Disease
prostaglandin E2, are discriminative in patients with active TB from those with LTBI and thus progression
might predict the potential of being active TB from LTBI. To compare the serum apoptosisassociated 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
Allocation: Randomized
Endpoint Classification: Efficacy
Study
Intervention Model: Parallel
Assignment
Masking: Open Label
Allocation: Randomized
Intervention Model: Parallel
Assignment
Masking: Open Label
Primary Purpose: Diagnostic
2000
Recruiting
NCT01685905
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
Not yet recruiting
NCT02651259
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 inperson DOT
310
Not yet recruiting
NCT02641106
3000
Recruiting
NCT02119130
8200
Recruiting
NCT02276755
322
Recruiting
NCT02208427
500
Not yet recruiting
Sponsor:
National Institute of Allergy and Infectious Diseases
(NIAID)
•Drug: Isoniazid (INH)
900 mg of INH
Video Directly Observed Therapy,
Person DOT (Control)
•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.
Not provided
In-
Sponsor:
University of California, San Diego
USA
Sponsor:
Johns Hopkins University
Device: QGIT
South Africa
Collaborators:
National Institute of Allergy and Infectious Diseases
(NIAID)
The goal of this clinical trial is to investigate the preventive role of vitamin D supplementation Treatment/intervention
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 from the intervention.
The incidence of TB in Taiwan has gradually declined in recent 10 years. In order to maintain Treatment/intervention
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.
•Drug: Rifapentine (RPT)
900 mg of RPT
•Dietary Supplement: Pyridoxine (vitamin B6)
25 mg to 100 mg of pyridoxine, based on the
current local, national, or international dosing
guidelines.
Interventional
A novel mHealth application that allows patients to make and send videos of each
Operational
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 clinicbased in-person DOT.
Korea, Republic of
Not provided
Collaborator:
Bristol-Myers Squibb
Interventional
Observational
Phase 3, Allocation: Randomized
Intervention Model: Parallel
Assignment
Masking: Double Blind (Subject,
Caregiver, Investigator,
Outcomes Assessor)
Primary Purpose: Prevention
•Other: Placebo
Placebo group will receive placebo (Tishcon,
USA) bi-weekly.
Phase 3 Allocation: Randomized Rifapentine and Isoniazid for 3 months versus
Endpoint Classification:
Isoniazid for 9 months
Safety/Efficacy Study
Intervention Model: Parallel
Assignment
Masking: Open Label
Primary Purpose: Prevention
Observational Model: Defined
Population
Time Perspective: Longitudinal
Observational Model: Case
Control
Time Perspective: Prospective
University of Witwatersrand, South Africa
•Dietary Supplement: cholecalciferol (vitamin D)
14000 IU vitamin D3 weekly Experimental group
will receive vitamin D supplement (Tishcon,
USA).
Not provided
Taiwan
Not provided
Ethiopia
Taiwan
Healthy children ages between 6 and
13 years, enrolled in participating
schools
Not currently TB infected.
Sponsor:
National Taiwan University Hospital
Sponsor:
Liverpool School of Tropical Medicine
Collaborator:
Thrasher Research Fund
Not provided
Observational
Sponsor:
Harvard School of Public Health
National Taiwan University Hospital
Children with suspicion of TB
attending health centres will also be
investigated
1.Patients with tuberculosis:
microbiology or pathology proven
tuberculosis infection
2.Patients with latent tuberculosis
infection are defined by interferongamma release assay
3.Patients without tuberculosis and
latent tuberculosis are defi=ed by
negative findings in above-mentioned
results
NCT00456469
400
Recruiting
30
Recruiting
NCT01676155
•Biological: Aerosol inhaled MVA85A
Other Name: MVA85A
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: Intramuscular MVA85A
Other Name: MVA85A
•Biological: Intramuscular Saline placebo
Other Name: Saline
•Biological: Aerosol inhaled Saline placebo
Other Name: Saline
UK
Sponsor:
University of Oxford
Collaborator:
University of Birmingham
NCT02532036
The objective of this study is to assess the efficacy of the two current TB (tuberculosis) blood Diagnostic and disease
tests (Interferon Gamma Release Assays (IGRA)) compared with the standard skin test
progression
(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.
Observational Model: Cohort
Time Perspective: Prospective
Not provided
Sponsor:
Public Health England
Collaborators:
United Kingdom
Observational
Imperial College London
Queen Mary University of London
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
Active, not recruiting
NCT01162265
Household contacts exposed to
patients with sputum smear positive
tuberculosis that are:
1. Above the age of 5 years
2. HIV negative
3. Tested positive on both the
tuberculin skin test and the
QuantiFERON®-TB Gold In-Tube® test
145
completed
ISRCTN15705625
Child between 2 and 17 years, who
have had contact with tuberculosis
24
Recruiting
NCT02581579
The study will enrol participants with
LTBI
250
Recruiting
NCT02225158
Persons with clinical indication for
latent tuberculosis infection (LTBI)
treatment.
80
Closed: follow-up
continuing
ACTRN12613000599
774
4000
Recruiting
NCT01547884
350
Active, not recruiting
NCT01549457
3000
Active, not
recruiting
NCT01404312
150
Recruiting
NCT01212003
University College, London
Brunel University
Isoniazid is an antibacterial drug used to treat active TB infections. This drug is also
commonly used to prevent active TB developing in people who have come into contact with
an infected person. The aim of this study is understand the way that isoniazid preventative
treatment (IPT) affects the body in people with latent TB, and if it can increase immunity to
TB in general.
Treatment
Radomised controlled trial
nested within a cohort study
(Treatment)
Interventional
This is a double-blind, masked, compared with placebo clinical trial in pediatric population in Disease progression and risk
contact with tuberculosis with or without tuberculosis infection. This trial aims to study the factors
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.
Interventional
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.
To study how the immune system of people with latent tuberculosis infection (LTBI) acts to Disease progression and risk
prevent development of active TB. Also, to study how helminth infection might affect this
factors
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.
Household contacts that were eligible for the
study were randomized to receive either
isoniazid preventive therapy (IPT) and monthly
visits or monthly visits only. Household contacts
in the IPT arm were offered self-administerd
isoniazid (5mg/kg to a max of 300mg) plus
pyridoxine 25mg daily for six months.
Phase 1
Allocation: Dietary Supplement: Nyaditum resae ® 10e5 of
Randomized, Endpoint
heat-killed Mycobacterium manresensis
Classification: Safety/Efficacy
Other: Placebo
Study, Intervention Model:
Parallel Assignment, Masking:
Double Blind (Subject, Caregiver,
Investigator), Primary Purpose:
Prevention
University of Birmingham
College of Health Sciences, Makerere University
Uganda
Sponsor:
Manresana de Micobacteriologia, SL
Spain
Sponsor: National Institute of Allergy and Infectious
Diseases (NIAID)
United States
Observational
Study Design:
Time Perspective: Prospective
The aim of this study is to perform a multimodal comparison of 3-month courses of weekly
isoniazid and rifapentine (3HR) with 9 months of daily isoniazid (9H) for latent tuberculosis
infection, using a variety of indices:
Operational
A 12 dose course of weekly isoniazid (900mg)
and rifapentine (900mg) tablets.
Other (immunology,
pathogenesis, co-infection)
Time Perspective: CrossSectional
not provided
Interventional
Sponsor:
United States
Observational
This study will examine the impact of use of mobile phones and text messaging on adherence Operational
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.
Sponsor: Hospital Melbourne Health
Australia
Interventional
a. Cost-benefit
b. Patient satisfaction
c. Adherence to prescribed therapy
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.
Randomised controlled trial
Parallel
Phase: Phase 4
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.
National Institute of Allergy and Infectious Diseases
(NIAID)
Treatment/intervention
To provide better training for infectious disease staff members at the National Institutes of
Operational/programmatic
Health Clinical Center in Washington, D.C., researchers are interested in actively recruiting
and basic science
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.
Interventional
Phase 3
Allocation: Dietary Supplement: Pyridoxine (Vitamin B6)
Randomized, Intervention
Drug: Isoniazid (INH)
Model: Parallel Assignment,
Drug: Rifapentine (RPT)
Masking: Open Label, Primary
Purpose: Prevention
- Individuals between 18 and 65 years
of age who have latent TB and may or
may not have filarial infection.
Sponsor:
University of British Columbia
Collaborator:
Canada
British Columbia Cancer Agency
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.
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.
Eligibility:
Inclusion Criteria:
Are initiating treatment for latent TB
infection
Sponsor:
United States,
Botswana, Brazil, Haiti, National Institute of Allergy and Infectious Diseases
Kenya, Malawi, Peru, (NIAID)
South Africa, Thailand,
Zimbabwe
Time Perspective: Prospective
HIV + persons with latent TB
Sponsor:
National Institute of Allergy and Infectious Diseases
(NIAID)
United States
Observational
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.
Ibrahim Abubakar
Steven Graham (Austrailia)
Phillipe LoBue (USA)
To assess the efficacy of preventive therapy (levofloxacin versus placebo) in all contacts
(adults and children)
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.
Dick menzies
Ibrahim Abu bakar (UK)
The RD1 based ex vivo enzyme linked
immunospot assay versus Tuberculin PPD RT 23
SSI for mantoux testing
Observational
Treatment/intervention
Interventional
Observational
Interventional
The current standard regimen is 9 months of Isoniazid (9INH). This regimen has excellent Treatment/intervention
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.
Once children are exposed and infected they are at very high risk to develop active TB Treatment/intervention
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.
Currently available blood tests for latent tuberculosis infection (LTBI) identify people
Diagnostic and disease
who have been previously infected with M. tuberculosis. Whilst they are sensitive and
progression
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.
Interventional
Interventional
Interventional
Latent tuberculosis infection
Randomised controlled trial
Parallel
Renal failure and iatrogenic
immunosuppression associated with
solid organ transplantation or TNF
alpha blockade in rheumatoid arthritis
multiple: UK,
NHMRC, Vietnam National Treatment Program
Vietnam
Multi centre phase III, double
blind RCT
24 weeks of daily levofloxacin against 24
weeks of daily placebo
Observational Model: Cohort
Time Perspective: Prospective
not provided
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)
Phase 3
Allocation:
Randomized
Endpoint Classification:
Efficacy Study
Intervention Model: Parallel
Assignment
Masking: Open Label
Primary Purpose: Treatment
Isoniazid versus Rifampin
Phase 3
Allocation: Randomized
Endpoint Classification: Safety
Study
Intervention Model: Parallel
Assignment
Masking: Open Label
Primary Purpose: Treatment
Drug: Isoniazid verusu Rifampin
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
South Africa
10 sites across the
United States
•Behavioral: SMS reminders
Short Message Service (SMS) text reminders
•Drug: isoniazid and rifapentine
100
Completed
ISRCTN04379941
On going
EudraCT Number:
2005-005664-88
Sponsor: University of Oxford
UK-multicentre
Six months of daily oral levofloxacin
Interventional
Operational and diagnostic
and disease progression
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.
The trial is conducted in patients diagnosed with latent tuberculosis infection (LTBI) who Operational
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).
Sponsor: University College London
UK-multicentre
Treatment/intervention
Phillipe LoBue (USA)
Dick menzies
Random allocation to either Rifinah (Rifampicin
plus Isoniazid) or Rifapentine and Isonazid.
Interventional
To validate the use of the RD1 based Exvivo IFNy ELISpot in the immunodiagnosis of
Diagnostic biomarkers and
tuberculosis in iatrogenically immunosuppressed populations by calculation of positive and Disease progression
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.
Steven Graham (Austrailia)
Unblinded RCT
Treatment/intervention
United States, China,
South Africa, Spain
Australia, Benin,
Brazil, Canada, Ghana,
Guinea, Indonesia,
Korea, Republic of,
Saudi Arabia
Household contacts (adults,
adolescents, and children down to 3
kg) of individuals with MDR-TB
Joint Global Health Trials Scheme of the Department for
Child <5 years who is household
International Development (UK), Wellcome Trust,
contact of an enrolled adult MDR-TB
Medical Research Council, South African Medical
case
Research Council
Tuberculosis Epidemiologic Studies Consortium II
(TBESC II)
Sponsor:
Centers for Disease Control and Prevention
ponsor:
McGill University
Collaborator:
Canadian Institutes of Health Research (CIHR) Principal
Investigator: Dr. Dick Menzies
High risk individuals for latent TB,
including children and
immunocompromised persons.
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)
2006
Recruiting
1556
Completed
42647
Recruiting
ACTRN12600021542
6
ISRCTN92634082
Steven Graham (Austrailia)
Steven Graham (Austrailia)
Phillipe LoBue (USA)
NCT01622140
1002
completed
5720
Active, not
recruiting
NCT01582711
Phillipe LoBue (USA)
Dick menzies
NCT00931736
Sponsor:
McGill University
Collaborator:
Canadian Institutes of Health Research (CIHR)
Australia, Benin,
Brazil, Canada, Ghana, Information provided by (Responsible Party):
Guinea, Indonesia
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
Completed
NCT00170209
Dick menzies
2000
Recruiting
NCT02512939
Ibrahim Abu bakar (UK)
Sponsor:
Public Health England
UK
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.
Ibrahim Abu bakar (UK)
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
Prospective cohort
Observational
Operational &
programmatic
Cohort
Procedure: venepuncture, sputum collection,
xray
venepuncture, sputum collection, xray
Latent TB testing and treatment programmes
Observational
Ibrahim Abu bakar (UK)
Treatment of latent TB in primary care compared to secondary care
Ibrahim Abu bakar (UK)
Predictive value of the two commercial IGRAs compared to TST
Operational &
programmatic
Observational
Prognostic
To evaluate the effect of BCG vaccination after treatment of latent TB infection
Cohort
Treatment
UK
Multiple: UK,
Netherlands, Sweden,
Italy, Romania and
Bulgaria
A cluster randomised controlled Treatment of LTBI in primary care
trial
Observationa
Ibrahim Abu bakar (UK)
Sponsor: Public Health England
Principle investigator: Ibrahim Abubakar
Pilot trial
UK
Two commercial IGRAs (T-Spot TB and
Quantiferon, TST)
Biobank for substudies
Prognostic value of the next generation quantiferon test and biomarkers for progression
Ibrahim Abu bakar (UK)
Diagnostic and disease
progression
Assess prevalence of latent TB in hard to reach groups
Observational
Cohort
Operational &
programmatic
BCG, serial IGRA
IGRA (4th Gen)
Biobank for substudies
UK Multi-Centre
IGRA tests
Assess prevalence of latent TB in migrants
Screening for latent TB infection in migrants using IGRA and analysis of progression to disease Operational & programmatic
following 6 months IPT.
Brita Askeland Winje (Norway)
Brita Askeland Winje (Norway)
Brita Askeland Winje (Norway)
Gerard de Vries
Gerard de Vries
Observational
The purpose of the study is to explore risk factors for TB in Norway and assess the targeting Operational & programmatic
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.
Data will include all cases prescribed with LTBI treatment in Norway in 2016. The data to be Operational & programmatic
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.
This is a qualitative study among immigrants run by an NGO (LHL international) aiming to
identify barriers to screening for TB.
Operational & programmatic
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.
Operational
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
Ibrahim Abu bakar (UK)
Migrants
Ibrahim Abu bakar (UK)
Contacts, Migrants
10,000
Ibrahim Abu bakar (UK)
Ibrahim Abu bakar (UK)
NIHR,
University College London
Ibrahim Abubakar
Chief investigator:
Adult contacts of pulmonary TB
2,000
Ibrahim Abu bakar (UK)
Contacts, Migrants and others at risk
of LTBI
IGRA
Ibrahim Abu bakar (UK)
Funder: NIHR
Chief Investigator: Andrew Hayward
UK
Hard to reach groups
Ibrahim Abu bakar (UK)
Migrants
Ibrahim Abu bakar (UK)
Chief Investigator: Manish Pareek
Observational
Dr Constantia Voniatis (Cyprus)
Barts Charity
Chief investigator: Heinke Kunts
Co-aaplicant: Ibrahim Abubakar
2016-2018
Funder: UK Department of Health
Sponsor: Public Health England
Principle investigator: Ibrahim Abubakar
Operational & programmatic
Ibrahim Abu bakar (UK)
Various
UK
Cross sectional study
Ibrahim Abu bakar (UK)
MRC
Principle investigator (UK):
Ibrahim Abubakar, Brazil (Sergio Arruda)
Observational
Ibrahim Abu bakar (UK)
NCT02512484
Chief
UK
Observational
Ibrahim Abu bakar (UK)
Not yet recruiting
2013-2016
Brazil
Cohort
The impact and value for money of peer support to improve clinical engagement in
hard-to- Operational &
reach individuals with hepatitis C virus (HCV) will be assessed.
Assessment of completion
programmatic
rates for a novel, short, LTBI treatment regimen.
EU Third Health Programme
investigator : Ibrahim Abu bakar
1000
Chief investigator: Ibrahim Abubakar
Interventional
Ibrahim Abu bakar (UK)
Individuals at high risk of TB
Observational
Observational
Observational
Cohort
IGRA
UK
Prospective cohort
LTBI intervention
Cyprus
Norway
Register-based study
Prospective cohort
Norway
Qualitative study
Observational
Multiple pilot studies Prospective
cohort
Observational
Retrospective cohort
Norway
LTBI intervention
The Netherlands
Evaluation
The Netherlands
Sponsor: Under negotiation
Center for Communicable Disease Control, Makarios III
Hospital, Nicosia
Pulmonology Clinic, Nicosia General Hosp.
University of Nicosia
Norwegian Health Association (NHA)
Norwegian Institute of Public Health (NIPH)
Norwegian Heart and Lung Association (LHL
International)
ZonMw (The Netherlands Organization for Health
Research and Development) – Govt institution.
KNCV, RIVM, Municipal Health Services, Universities
KNCV
Migrant workers
All cases with an IGRA result
(positive and negative) OR TB or
LTBI treatment
LTBI cases
1000
Planning stage
80000
Active
App 700
25
Immigrants
• Regular immigrants
• Asylum seekers
• Somali and Eritrean population
LTBI cases
Active
Active
On going
(2015-2019)
37,729
Manuscript
excepted in ERJ
To be announced
Information will
soon be available
on the web
http://www.zonmw.
nl/nl/projecten/proj
ect-detail/tbendpointtuberculosiselimination-in-thenetherlands-throughdisease-preventionoptimalization/same
Dr Constantia Voniatis (Cyprus)
Brita Askeland Winje (Norway)
Brita Askeland Winje (Norway)
Brita Askeland Winje (Norway)
Gerard de Vries
Gerard de Vries
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
Gerard de Vries
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.
Observational
Retrospective cohort
Evaluation
The Netherlands
KNCV
LTBI cases
Observational
Retrospective cohort
Evaluation
The Netherlands
KNCV
LTBI cases
Manuscript in
preparation
Gerard de Vries
Manuscript in
preparation
Gerard de Vries
Operational
Gerard de Vries
>60,000 contacts
screened
National data collection and analysis of LTBI screening policy, practices and results of clinical Programmatic
risk groups in hospitals, as part of the National TB Control Plan 2016-2020.
Gerard de Vries
Evaluation
Assessing predicitive value of IGRA and to understand the contributing risk factors towards
progression of disease.
Gerard de Vries
Prospective
Evaluation
The Netherlands
KNCV
LTBI cases
Retrospective cohort
Evaluation
The Netherlands
KNCV
LTBI cases
2016-2020
The National TB
Control Plan will be
published soon (in
Dutch) and sent out
for translation.
Gerard de Vries
Diagnostic and disease
progression
Observational
4000
Planned
Gerard de Vries