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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. Is unable to take oral medications
. Persons with any other medical condition, precluding study participation based on investigator judgement
. Any co-existing condition that in the opinion of the attending clinician renders the participant unsuitable for participation in the study
. Co-enrolment in other interventional research studies