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

NCT05553236 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2500

Last updated 2026-01-26

No results posted yet for this study

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.

Conditions

  • Drug-resistant Tuberculosis
  • HIV Coinfection
  • Cost-Benefit Analysis

Interventions

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.

Sponsors & Collaborators

  • University of Stellenbosch

    collaborator OTHER

  • National Health Laboratory Service (NHLS), South Africa

    collaborator UNKNOWN

  • National Institute for Communicable Diseases, South Africa

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Find

    collaborator OTHER

  • Translational Genomics Research Institute

    collaborator OTHER

  • University Hospital Heidelberg

    collaborator OTHER

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • John Z Metcalfe, MD, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • South Africa

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05553236 on ClinicalTrials.gov