Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2401 participants
OBSERVATIONAL
2019-12-05
2021-06-30
Brief Summary
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Detailed Description
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TB can infected the lungs (pulmonary TB) or other organs such as the brain, and kidneys (extra-pulmonary TB). When a person with pulmonary TB coughs or sneezes, water droplets containing M. tuberculosis are expelled into the air. Persons can become infected with TB when they inhale air containing these water droplets, however, not everyone infected with Mycobacterium tuberculosis (Mtb) becomes ill. Therefore two TB-related conditions exist: latent TB infection (LTBI) and TB disease.
People with latent TB infection are not ill and do not present TB symptoms or have TB disease. The only sign of TB infection is a positive reaction to the tuberculin skin test or TB blood tests such as IGRA tests. People with latent TB infection are not contagious and cannot spread TB infection to others.
Identification and treatment of LTBI can substantially reduce the risk of developing active disease. However, there is no diagnostic gold standard for LTBI. Two types of test are currently available for the identification of LTBI: the tuberculin skin test (TST) and the TB Interferon Gamma (IFN-γ) Release Assay (TB-IGRA). Evidence suggests that both TST and TB-IGRA are acceptable but not perfect because they detect indirect markers of Mtb exposure and indicate a cellular immune response to M. tuberculosis. TB-IGRAs have a number of advantages compared to TST which promote their progressive adoption in the clinical practice and in guidelines.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Active Tuberculosis Patient
Blood draw and IGRA test
One to two blood samples will be obtained from participants in all arms in order to conduct testing.
High risk for LTBI Participant
Blood draw and IGRA test
One to two blood samples will be obtained from participants in all arms in order to conduct testing.
Low risk for prior TB infection Participant
Blood draw and IGRA test
One to two blood samples will be obtained from participants in all arms in order to conduct testing.
NTM patient
Blood draw and IGRA test
One to two blood samples will be obtained from participants in all arms in order to conduct testing.
Precision patient
Blood draw and IGRA test
One to two blood samples will be obtained from participants in all arms in order to conduct testing.
Interventions
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Blood draw and IGRA test
One to two blood samples will be obtained from participants in all arms in order to conduct testing.
Eligibility Criteria
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Inclusion Criteria
A person with known HIV status, determined by a laboratory or rapid test performed no earlier than one month prior to, or at the time of inclusion into this study A person of age ≥ 2 years
A person who is at increased risk for M. tuberculosis infection (and therefore LTBI) and/or for progression to active TB:
A person with age ≥ 2 years A person with known HIV status
A person who has or has had active TB A person who has received treatment for active TB or LTBI A person who has received an anti-TNF alpha treatment A person who has had a TST Pregnant women Person who has been an NTM infection
Low Risk for TB Infection
Generally healthy people, unlikely to have encountered TB disease in the past, that may be subject to TB testing for professional, academic or personal reasons (e.g.: students, healthcare personnel and healthcare volunteers, military recruits) A person with age ≥ 18 years old
NTM population:
Precision Population
A person previously enrolled in the Active TB, High Risk or Low Risk studies, or a blood donor.
For blood donors only:
A person who can be classified as being at increased risk for M. tuberculosis infection (and therefore LTBI) and/or for progression to active TB
Exclusion Criteria
High Risk for TB infection
2 Years
ALL
Yes
Sponsors
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BioMérieux
INDUSTRY
Responsible Party
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Principal Investigators
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David Pride
Role: PRINCIPAL_INVESTIGATOR
UC San Diego
Maria Gennaro
Role: PRINCIPAL_INVESTIGATOR
Rutgers University
Michael Lauzardo
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Niaz Banaei
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Nahed Ismail
Role: PRINCIPAL_INVESTIGATOR
University of Illinois Chicago
Daniel Hoft
Role: PRINCIPAL_INVESTIGATOR
St. Louis University
Charles Daley
Role: PRINCIPAL_INVESTIGATOR
National Jewish Health
Amanda Lopes
Role: PRINCIPAL_INVESTIGATOR
Lariboisière Hospital
Frederic Méchaï
Role: PRINCIPAL_INVESTIGATOR
Avicenne Hospital
Florence Doucet-Populaire
Role: PRINCIPAL_INVESTIGATOR
Antoine-Béclère Hospital
Elisabeth Botelho-Nevers
Role: PRINCIPAL_INVESTIGATOR
North Hospital
Locations
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Stanford University
Palo Alto, California, United States
UC San Diego
San Diego, California, United States
Naional Jewish Health
Denver, Colorado, United States
University of Florida
Gainesville, Florida, United States
University of Illinois- Chicago
Chicago, Illinois, United States
Saint Louis University
St Louis, Missouri, United States
Rutgers University
Newark, New Jersey, United States
Universidade Federal de Mato Grosso do Sul (UFMS)
Campo Grande, , Brazil
Universidade Federal Da Grande Dourados (UFGD)
Dourados, , Brazil
Anti-TB center of Chambéry
Chambéry, , France
Lapeyronie Hospital
Montpellier, , France
Anti-TB center of Nanterre
Nanterre, , France
Avicenne Hospital
Paris, , France
Lariboisière Hospital
Paris, , France
North Hospital
Saint-Etienne, , France
National Center for Tuberculosis and Lung Disease
Tbilisi, , Georgia
Hinduja Hospital
Mumbai, , India
INMI L. Spallanzani
Rome, , Italy
Autonomous University of Baja California
Mexicali, , Mexico
TASK Applied Science, Delft Day Hospital Premises
Cape Town, , South Africa
University of Cape Town Centre for Lung Infection and Immunity
South Africa, , South Africa
Evelina London Children's Hospital
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
St Thomas' Hospital
London, , United Kingdom
Countries
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Other Identifiers
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B2694-CTPR
Identifier Type: -
Identifier Source: org_study_id
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