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 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT04781257
Eligibility Criteria:
Inclusion Criteria:
TB index case:
* Aged at least 18 years
* Having at least one other person living in the household aged ≥10 years
* Written informed consent to conduct socio-economic and clinical questionnaire, to provide a sputum sample for culture and sequencing, and to approach the household members.
* Recently diagnosed with active pulmonary TB within the last 4 weeks
* Has taken less than 7 daily doses of anti-TB treatment since diagnosis; ensuring a positive culture can still be obtained
* Able to spontaneously produce sputum
* Sputum microscopy positive in Ziehl-Neelsen or Auramine-O staining of ideally 2+ or higher, but at least 1+ on the IUATLD/WHO scale, OR (in case no sputum microscopy done) GeneXpert positive, at least TB "medium"
* A firm home address, maintained unchanged for the last 6 months, that is accessible to visiting
Household Contact:
* Aged at least 10 years
* Written informed consent for study participation, including HIV testing, and home visits by the study team for follow-up (for minors \<18 yr.: consent of the parent/guardian, assent of the participant)
* Recent (in the last 4 weeks), substantial exposure to an infectious TB case in the household, defined as sleeping at least 3/7 nights in the same household
* If HIV negative: not on preventive therapy (preventive therapy is not an exclusion criterion for HIV positive persons)
Exclusion Criteria:
Household Contact
* Circumstances that raise doubt on free, uncoerced informed consent (e.g. in a mentally handicapped person)
* Prisoners
* Recent treatment for active TB, completed within the last 30 days OR on current TB treatment for active TB.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT04781257
Study Brief:
Protocol Section:
NCT04781257