Actively Recruiting

Phase Not Applicable
All Genders
NCT05553236

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

Led by University of California, San Francisco · Updated on 2026-01-26

2500

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

U

University of Stellenbosch

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Active rifampin-resistant tuberculosis diagnosed at a study facility during the study period
  • Positive Mycobacterium tuberculosis culture, smear, or specimen derivative (e.g., GenoLyse remnant, Xpert cartridge extract)
Not Eligible

You will not qualify if you...

  • Patient expects to relocate or move residence outside of the study region
  • Patient does not agree to participate in the study
  • Participants later found to have rifamycin susceptibility on at least two additional tests (e.g., phenotypic DST, LPA, or sequencing) will be excluded

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

South African National Health Laboratory Service

Cape Town, South Africa

Actively Recruiting

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Research Team

J

John Z Metcalfe, MD, PhD

CONTACT

R

Rob Warren, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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