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 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT04583904
Eligibility Criteria:
Phase I
1\. Eligibility for hospitalized and ambulatory adults:
* ≥16 years old
* Positive Xpert MTB/RIF Ultra test (TB-positive cohort) or no suspicion of clinical TB (TB-negative cohort)
* Have a documented HIV test result or agrees to test for HIV
* Have NOT received IPT within prior 3 months
* Have NOT received anti-TB treatment for more than 24 hours
* Willing/able to provide written informed consent
Phase II:
1. Eligibility for hospitalized adults:
* ≥16 years old
* Admitted to inpatient medical ward \<72 hours
* Have a documented positive HIV test
* Have NOT received IPT within prior 3 months
* Have NOT received anti-TB treatment for more than 24 hours
* Willing/able to provide written informed consent
Study population description:
2. Eligibility for Xpert+ adults (hospitalized and attending outpatient clinics)
* ≥16 years old
* Have a documented HIV test result or agrees to test for HIV
* Positive Xpert MDR/RIF Ultra test documented.
* Have NOT received anti-TB treatment for more than 24 hours
* Willing/able to provide written informed consent
3\) Eligibility for children
* children \<12 years of age
* suspected of having active TB disease by clinical team
* Have a documented HIV test result or agrees to test for HIV
* Have not had IPT within 3 months
* Have not received anti-TB treatment for more than 24 hours within the prior 5 days
* Parent or guardian is willing/able to provide written informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Study:
NCT04583904
Study Brief:
Protocol Section:
NCT04583904