Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT06221735
Eligibility Criteria:
Inclusion Criteria:
* All participants:
* Agree to remain in contact and provide updated information as necessary, and have no current plans to relocate outside the designated area for the duration of the study
* Capable of providing signed informed consent and informed assent (as appropriate)
* Group 1:
\+ Microbiologically-confirmed pulmonary TB (either drug-susceptible TB or drug-resistant TB) via Xpert MTB/RIF or Xpert MTB/RIF Ultra (Cepheid, Sunnyvale, California) and abnormal chest X-ray (CXR) result\*
\*To reduce the false positive rate of molecular diagnostic assays for M. tuberculosis
* Group 2:
\+ Household contacts without symptoms of active TB disease of people with microbiologically-confirmed, pulmonary TB who initiated treatment with residents in Ha Noi, Vietnam.
* Group 3:
* Known past negative IGRA test results among those at low risk for TB infection
* No known and/or reported history of contact or exposure to either TB disease or M. tuberculosis bacteria.
Exclusion Criteria:
* All participants:
\+ Declines to provide informed consent to participate in the study
* Groups 2 \&3:
* Presumed TB disease with symptoms (cough, fever, night sweats, unintentional weight loss) and/or an abnormal CXR result suggestive of TB disease
* Microbiologically - or clinically-confirmed TB disease in all forms or report having taken treatment for TB disease.
* History of TB infection (self-record or documented).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06221735
Study Brief:
Protocol Section:
NCT06221735