NCT05175794Completed
Triage Test for All Oral DR-TB Regimen (TRiAD Study)
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
Source: ClinicalTrials.gov · Last updated 26 Jun 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 786 (actual)
- First submitted
- 22 Sept 2021
- Start date
- 26 May 2022
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Centre for the AIDS Programme of Research in South Africa
- Diseases
- Tuberculosis
- NCT number
- NCT05175794
What you commit to
- Study type: Observational
- Participants enrolled: 786
- From 26 May 2022 to the primary completion date, 31 Dec 2024
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Is unable to take oral medications
Other illness
- 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
- 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
Other
- Has TB meningitis, other central nervous system TB, or TB osteomyelitis; or
- Is pregnant or breastfeeding
- Co-enrolment in other interventional research studies
Who the study is looking for
- 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:
- 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
- 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
- Willing to have samples collected, stored indefinitely, and used for research purposes
- Able to provide reasonable proof of identity (to satisfaction of study team member) at or prior to enrolment
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ethiopian Public Health Institute (EPHI) Coordinator of this site? Confirm its status | Gulele | Ethiopia | Unknown status |
| Institute of Human Virology Nigeria Coordinator of this site? Confirm its status | Yaba | Nigeria | Unknown status |
| Clinical HIV Research Unit (CHRU), WITS Health Consortium Coordinator of this site? Confirm its status | Bethelsdorp | South Africa | Unknown status |
| CAPRISA Springfield Research Clinic Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.