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

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: HIV Coinfection; Drug-resistant Tuberculosis; Cost-Benefit Analysis

Treatments: Diagnostic Test: Targeted next-generation sequencing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05553236

AI153213

R01AI153213 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Enrollment: 2,500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,500 participants in 2 patient groups

Sequencing Intervention in addition to standard of care

Experimental group

Description:

Batched targeted deep sequencing in addition to the locally accepted standard of care drug susceptibility determination of multidrug/extensively drug-resistant tuberculosis (M/XDR-TB)

Treatment:

Diagnostic Test: Targeted next-generation sequencing

Standard of Care

No Intervention group

Description:

Locally accepted standard of care which is consistent with the WHO recommendations for the drug susceptibility determination of M/XDR-TB