Triage Test for All Oral DR-TB Regimen (TRiAD Study) (NCT05175794) | Clinical Trial Compass
CompletedNot Applicable
Triage Test for All Oral DR-TB Regimen (TRiAD Study)
Ethiopia, Nigeria, South Africa786 participantsStarted 2022-05-26
Plain-language summary
A Phase 4 operational study to assess the effectiveness, feasibility, acceptability, and cost effectiveness of the GeneXpert MTB/XDR (Xpert XDR; Cepheid) assay for rapid triage-and-treatment of DR-TB-A multi-centre, multi-country prospective cohort study
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Ambulant adults ≥ 18 years of age
✓. Newly diagnosed PTB patients receiving less than 5 days of treatment since new diagnosis:
✓. Cohort 1: \< 5 days of DR-TB treatment
✓. Cohort 2: \< 5 days of INH mono-resistant TB treatment preceding study entry for the current TB episode, or
✓. Sputum positive (smear and or culture) TB patients classified as failing first line treatment
✓. Any currently available Nucleic Acid Amplification Tests for drug-resistance detection changes/assay positive for M.tb infection with:
✓. Capacity to provide informed consent
✓. 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
Exclusion criteria
✕. Has a known severe allergy to any of the BPaL component drugs
✕. Has DST showing infection with a strain resistant to any of the component drugs
✕. Has TB meningitis, other central nervous system TB, or TB osteomyelitis; or
✕. Is pregnant or breastfeeding
✕
What they're measuring
1
Time to initiation
Timeframe: 4 years
2
Proportion of patients with favorable treatment outcomes
Timeframe: 4 years
Trial details
NCT IDNCT05175794
SponsorCentre for the AIDS Programme of Research in South Africa