Epidemiologic study to assess the IGRA positivity in populations with a high TBburde
- Registration Number
- CTRI/2023/01/048867
- Lead Sponsor
- Bill & Melinda Gates Medical Research Institute (Gates MRI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Capable of giving signed informed consent and informed assent (as appropriate), which includes compliance with the requirements listed in the informed consent form (ICF) and informed assent form (IAF)
2. Between 15 and 34 years of age (inclusive)
3. Participants who agree to stay in contact with the study site for the duration of the study,
provide updated contact information as necessary and have no current plans to relocate from the study area for the duration of the study.
1. History of active TB within the last 24 months (i.e., 24 months from end of treatment to day
of screening, based on history [no documentation required])
2. History of previous administration of an experimental Mtb vaccine
3. Unstable/uncontrolled chronic condition according to the judgment of the investigator.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of participants with positive IGRA, per site, calculated using the per protocol population.Timepoint: IGRA status (positive/negative/indeterminate) <br/ ><br>at screening (i.e) Day 1
- Secondary Outcome Measures
Name Time Method 1. Proportion of participants with positive IGRA, summarized by age group (15 to 24 [inclusive], and <br/ ><br>25 to 34 years of age [inclusive]) per site. <br/ ><br>2. Incidence rate of suspected pulmonary TB, summarized overall. <br/ ><br>3. Incidence rate of laboratory-confirmed pulmonary TB, summarized overall.Timepoint: 1. Time Frame: Screening <br/ ><br>2. Time Frame: Day 1 up to 30 months <br/ ><br>3. Time Frame: Day 1 up to 30 months