Using advanced genetic testing to manage drug-resistant tuberculosis
Targeted Sequencing to Enhance, Liberate, and Optimize Treatment of Drug-resistant Tuberculosis
This study tests if advanced genetic testing can help doctors make better treatment choices for people with drug-resistant tuberculosis to improve their health outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2500 (estimated) |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (Cape Town) |
| Trial ID | NCT05553236 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of a next-generation sequencing approach in managing rifampin-resistant tuberculosis (RR-TB) and improving patient outcomes. It employs a stepped-wedge, cluster randomized design to assess how this genetic testing strategy influences treatment decisions and health results. Participants include individuals diagnosed with active RR-TB at designated facilities, and the study aims to provide insights into the cost-effectiveness of this innovative management strategy.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with active rifampin-resistant tuberculosis who are receiving care at participating facilities.
Not a fit: Patients who do not have active RR-TB or those who are unwilling to participate in the study may not benefit.
Why it matters
Potential benefit: If successful, this approach could lead to more effective treatment strategies for patients with drug-resistant tuberculosis.
How similar studies have performed: Other studies utilizing next-generation sequencing for tuberculosis management have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Active RR-TB diagnosed at a study facility during the study period 2. Positive Mtb culture, smear, or specimen derivative (e.g., GenoLyse remnant, Xpert cartridge extract) Exclusion Criteria: 1. Patient expects to relocate/move residence outside of the study region 2. Patient does not agree to participate in the study In addition, participants later found to have isolates with rifamycin susceptibility on at least two additional tests (e.g., phenotypic DST, LPA, or sequencing) will be considered late exclusions.
Where this trial is running
Cape Town
- South African National Health Laboratory Service — Cape Town, South Africa (Recruiting)
Study contacts
- Principal investigator: John Z Metcalfe, MD, PhD — University of California, San Francisco
- Study coordinator: John Z Metcalfe, MD, PhD
- Email: john.metcalfe@ucsf.edu
- Phone: +14152068314
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.