Pragmatic Use of Next-generation Sequencing for Management of Drug-resistant Tuberculosis
Recruiting · NCT05553236 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, San Francisco
View the official record on ClinicalTrials.gov →Interventions studied
Targeted next-generation sequencing
What this trial is about
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 can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- South African National Health Laboratory Service - Cape Town, South Africa