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 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT01587469
Eligibility Criteria:
Inclusion Criteria:
* Suspected pulmonary TB (more information on the criterion can be found in the protocol)
* Men and women age equal to or greater than 18 years
* Ability and willingness of candidate or legal guardian/representative to provide informed consent
* Collection of two sputum samples for AFB smear and culture collected within 7 days prior to entry.
* Availability of two samples for Xpert MTB/RIF testing collected within 7 days prior to entry.
* Determination and/or documentation of HIV status
* For HIV-positive candidates, a CD4+ cell count obtained within 45 days prior to study entry or drawn at the time of entry at any laboratory that has a CLIA certification or its equivalent.
Exclusion Criteria:
* Either receipt of ≥48 cumulative hours OR three or more doses of anti-TB treatment within 180 days prior to completion of second sputum collection for Xpert testing
* Receipt of more than 7 cumulative days of antibiotics intended for bacterial treatment that may have anti-tuberculosis activity, within the 14 days prior to first sputum collection
* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01587469
Study Brief:
Protocol Section:
NCT01587469