Clinical trial NCT05553236: Pragmatic Use of Next-generation Sequencing for Management of Drug-resistant Tuberculosis
Official title: Targeted Sequencing to Enhance, Liberate, and Optimize Treatment of Drug-resistant Tuberculosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Drug-resistant Tuberculosis
HIV Coinfection
Cost-Benefit Analysis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Stellenbosch
name: National Health Laboratory Service (NHLS), South Africa
name: National Institute for Communicable Diseases, South Africa
name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Find
name: Translational Genomics Research Institute
name: University Hospital Heidelberg
First posted: 2022-09-23
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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 criteria: 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.

Primary outcomes:
measure: Number of participants with prespecified end of treatment outcomes
timeFrame: At the anticipated completion of prescribed treatment, up to 18 months
Secondary outcomes:
measure: 12-month relapse-free survival
timeFrame: From completion of prescribed treatment to death or TB recurrence, up to 12 months
measure: Exposure time to ineffective drugs
timeFrame: At the anticipated completion of prescribed treatment, up to 18 months
measure: Number of participants with acquired drug resistance
timeFrame: At the anticipated completion of prescribed treatment, up to 18 months
measure: Time to effective treatment initiation with three drugs
timeFrame: From diagnosis to treatment initiation with at least three effective drugs, up to 18 months
measure: Time to effective treatment initiation with four drugs
timeFrame: From diagnosis to treatment initiation with at least four effective drugs, up to 18 months
measure: Time to culture conversion
timeFrame: From diagnosis to stable culture conversion, up to 9 months
Other outcomes:
measure: Number of participants with clinical uptake of sequencing intervention results
timeFrame: At the anticipated completion of prescribed treatment, up to 18 months
measure: Cost-effectiveness of the sequencing intervention
timeFrame: At the anticipated completion of prescribed treatment, up to 18 months
Locations:
city: Cape Town
country: South Africa
facility: South African National Health Laboratory Service
Study officials:
affiliation: University of California, San Francisco
name: John Z Metcalfe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: