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 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT04567368
Eligibility Criteria:
Inclusion Criteria:
* Mtb-positive, rifampicin-resistant respiratory specimen identified on Xpert MTB/RIF Ultra
Exclusion Criteria:
* Residual SR-sputum mix not retained or not found
* Patient previously included in the study
Exclusion for diagnostic accuracy and time-to-result endpoints:
* Insufficient residual SR-sputum mix remaining for Xpert MTB/XDR (\<2 ml)
* Xpert MTB/XDR unsuccessful
* No second / follow-up specimen received
* Second / follow-up specimen culture-negative, contaminated or not available
* Reference standard uninterpretable (phenotyping or WGS)
* Where phenotypic susceptibility testing results are uninterpretable, specimens will still be included in WGS comparison
* Where WGS results are uninterpretable, specimens will still be included in phenotypic susceptibility testing comparison
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT04567368
Study Brief:
Protocol Section:
NCT04567368