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:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT05989802
Eligibility Criteria:
Participant eligibility criteria:
Participants will include children (age \<15 years) who present to care with:
A. 2 or more of the following:
* Unexplained cough for any duration
* TB contact or tuberculin skin test or interferon gamma release assay positive
* Abnormal chest X-ray (any abnormality) OR
B. Any one of criteria A AND any one of the following:
* Unexplained weight loss OR unexplained failure to thrive OR Severe Acute Malnutrition
* Unexplained fever ≥2 weeks
* Unexplained lethargy or reduced playfulness ≥2 weeks
The study will exclude participants who:
1. Completed preventive or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);
2. Have taken any medication with anti-mycobacterial activity for any reason for greater than 3 days at the time of enrollment (to reduce false-negatives);
3. Are unable to return for follow-up visits; or
4. Whose parents/guardians are unwilling to provide informed consent or who are unwilling to provide assent if applicable (age determined by local IRB)
Assessment of the usability of novel TB tests:
The study will also include health workers at each clinical site who are 1) aged ≥18 years and 2) involved in routine TB testing (collecting specimens for or performing TB tests). Personnel who are unwilling to provide informed consent will be excluded.
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
65 Years
Study:
NCT05989802
Study Brief:
Protocol Section:
NCT05989802