RecruitingNot ApplicableNCT05553236

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

Targeted Sequencing to Enhance, Liberate, and Optimize Treatment of Drug-resistant Tuberculosis


Sponsor

University of California, San Francisco

Enrollment

2,500 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This trial tests whether next-generation DNA sequencing can help guide better treatment decisions for people with drug-resistant tuberculosis (TB). You may be eligible if... - You have been newly diagnosed with rifampicin-resistant TB (RR-TB) at a study facility - You have a positive TB culture, smear, or a specimen that can be tested You may NOT be eligible if... - You plan to move outside the study region during the trial - You do not agree to participate - Later testing shows your TB is actually not resistant to rifampicin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTTargeted 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.


Locations(1)

South African National Health Laboratory Service

Cape Town, South Africa

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NCT05553236


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