Status:
COMPLETED
Epidemiologic Study to Assess the IGRA Positivity in Populations With a High TB Burden
Lead Sponsor:
Gates Medical Research Institute
Conditions:
Tuberculosis, Pulmonary
Eligibility:
All Genders
15-34 years
Brief Summary
The purpose of this study is to conduct a multi-country, multi-site, epidemiologic study designed to assess the proportion of interferon gamma release assay (IGRA) positivity, at site level, and to bu...
Eligibility Criteria
Inclusion
- 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)
- Between 15 and 34 years of age (inclusive)
- 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.
Exclusion
- History of active TB within the last 24 months (i.e., 24 months from end of treatment to day of screening, based on history \[no documentation required\])
- History of previous administration of an experimental Mtb vaccine
- Unstable / uncontrolled chronic condition according to the judgment of the investigator
- \-
Key Trial Info
Start Date :
December 20 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 16 2024
Estimated Enrollment :
7203 Patients enrolled
Trial Details
Trial ID
NCT05190146
Start Date
December 20 2021
End Date
August 16 2024
Last Update
December 13 2024
Active Locations (36)
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1
Investigational Site
Dhaka, Bangladesh, 1212
2
Investigational Site
Porto Alegre, Brazil, 90035-903
3
Investigational Site
Rio de Janeiro, Brazil, 21040-360
4
Investigational Site
Kinshasa, Democratic Republic of the Congo, 0000