Testing a new diagnostic tool for drug-resistant tuberculosis
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
Centre for the AIDS Programme of Research in South Africa · NCT05175794
This study is testing a new tool to quickly identify drug-resistant tuberculosis in patients from South Africa, Nigeria, and Ethiopia to help doctors choose the right treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1280 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Centre for the AIDS Programme of Research in South Africa (network) |
| Locations | 4 sites (Gulele, Addis Ababa and 3 other locations) |
| Trial ID | NCT05175794 on ClinicalTrials.gov |
What this trial studies
The TRiAD study is a multi-center, multi-country observational study aimed at evaluating the effectiveness, feasibility, acceptability, and cost-effectiveness of the GeneXpert MTB/XDR assay for the rapid triage and treatment of drug-resistant tuberculosis (DR-TB). It will screen approximately 4,800 patients across South Africa, Nigeria, and Ethiopia, enrolling individuals with rifampicin-resistant and isoniazid mono-resistant tuberculosis. The study will utilize the Xpert XDR assay to detect resistance to key anti-TB drugs, guiding the selection of appropriate treatment regimens. Additionally, the tuberculosis molecular bacterial load assay will monitor bacillary load during treatment to assess its effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are newly diagnosed with drug-resistant tuberculosis and have received less than 5 days of treatment.
Not a fit: Patients who have been on treatment for more than 5 days or those with non-drug-resistant tuberculosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the rapid diagnosis and treatment of drug-resistant tuberculosis, leading to better patient outcomes.
How similar studies have performed: Other studies have shown success with similar diagnostic approaches, indicating a promising potential for this method.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gulele, Addis Ababa and 3 other locations
- Ethiopian Public Health Institute (EPHI) — Gulele, Addis Ababa, Ethiopia (RECRUITING)
- Institute of Human Virology Nigeria — Yaba, Lagos State, Nigeria (RECRUITING)
- CAPRISA Springfield Research Clinic — Durban, KwaZulu-Natal, South Africa (RECRUITING)
- Clinical HIV Research Unit (CHRU), WITS Health Consortium — Bethelsdorp, Port Elizabeth, South Africa (RECRUITING)
Study contacts
- Principal investigator: Kogieleum Naidoo, MBCHB, PHD — Deputy Director -CAPRISA
- Study coordinator: Kogieleum Naidoo, MBCHB, PHD
- Email: kogie.naidoo@caprisa.org
- Phone: +27 31 655 0707
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Drug Resistant Tuberculosis, MDR-TB, XDR-TB, Tuberculosis, GeneXpert, Diagnostic Tool