RECRUITINGINTERVENTIONAL
Pragmatic Use of Next-generation Sequencing for Management of Drug-resistant Tuberculosis
Targeted Sequencing to Enhance, Liberate, and Optimize Treatment of Drug-resistant Tuberculosis
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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)
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DIAGNOSTIC_TEST
Targeted 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.
Locations (1)
South African National Health Laboratory Service
Cape Town, South Africa