Using advanced genetic testing to manage drug-resistant tuberculosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.