RecruitingNot ApplicableNCT05553236

Pragmatic Use of Next-generation Sequencing for Management of Drug-resistant Tuberculosis

Targeted Sequencing to Enhance, Liberate, and Optimize Treatment of Drug-resistant Tuberculosis

Sponsor

University of California, San Francisco

Enrollment

2,500 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Cost-Benefit Analysis Drug Resistant Tuberculosis HIV Coinfection

Summary

TS ELiOT is a stepped-wedge, cluster randomized trial assessing the effect of a next-generation sequencing-based strategy on rifampin-resistant tuberculosis management and patient outcomes.

Eligibility

Inclusion Criteria2

Active RR-TB diagnosed at a study facility during the study period
Positive Mtb culture, smear, or specimen derivative (e.g., GenoLyse remnant, Xpert cartridge extract)

Exclusion Criteria3

Patient expects to relocate/move residence outside of the study region
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.

Interventions

DIAGNOSTIC_TESTTargeted next-generation sequencing

During intervention periods, an additional patient sample derived from routinely collected specimens will be processed by a local technician. Extracted DNA extracted from these samples will be batched on a regular basis for targeted deep sequencing. Sequencing results will be regularly transmitted to a clinical advisory committee.