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 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT05175794
Eligibility Criteria:
Inclusion Criteria:
1. Ambulant adults ≥ 18 years of age
2. Newly diagnosed PTB patients receiving less than 5 days of treatment since new diagnosis:
1. Cohort 1: \< 5 days of DR-TB treatment
2. Cohort 2: \< 5 days of INH mono-resistant TB treatment preceding study entry for the current TB episode, or
3. Sputum positive (smear and or culture) TB patients classified as failing first line treatment
4. Any currently available Nucleic Acid Amplification Tests for drug-resistance detection changes/assay positive for M.tb infection with:
Cohort 1: at least Rifampicin resistance Cohort 2: Rifampicin susceptible co-occurring with INH, fluoroquinolone, ethionamide or aminoglycoside resistance (detected by Xpert XDR) occurring alone or in combination
5. Capacity to provide informed consent
6. HIV infected and uninfected participants are allowed in the study. Participants already on ART will be allowed in the study provided the ART regimen in use has no contraindications to the proposed TB drug regimen
7. Willing to have samples collected, stored indefinitely, and used for research purposes
8. Able to provide reasonable proof of identity (to satisfaction of study team member) at or prior to enrolment
Exclusion criteria:
1. Has a known severe allergy to any of the BPaL component drugs
2. Has DST showing infection with a strain resistant to any of the component drugs
3. Has TB meningitis, other central nervous system TB, or TB osteomyelitis; or
4. Is pregnant or breastfeeding
5. Is unable to take oral medications
6. Persons with any other medical condition, precluding study participation based on investigator judgement
7. Any co-existing condition that in the opinion of the attending clinician renders the participant unsuitable for participation in the study
8. Co-enrolment in other interventional research studies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05175794
Study Brief:
Protocol Section:
NCT05175794