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NCT Number: NCT05553236

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

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.

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Key information

Conditions

Drug-resistant Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Cost-Benefit Analysis Genital Diseases Gram-Positive Bacterial Infections HIV Coinfection HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mycobacterium Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tuberculosis Tuberculosis, Multidrug-Resistant Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South African National Health Laboratory Service

Cape Town, South Africa

Location status: Recruiting

Location contact

Nabila Ismail, PhD

CONTACT

[email protected]

Robin M Warren, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Active RR-TB diagnosed at a study facility during the study period
  • Positive Mtb culture, smear, or specimen derivative (e.g., GenoLyse remnant, Xpert cartridge extract)

Exclusion criteria

  • Patient expects to relocate/move residence outside of the study region
  • 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.

Treatment and study plan

Targeted next-generation sequencing

Diagnostic Test

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.

Primary outcomes

  1. Number of participants with prespecified end of treatment outcomes

    Time frame: At the anticipated completion of prescribed treatment, up to 18 months

    The number of participants with each of the following prespecified end of treatment outcomes will be reported: cure, treatment completed, loss to follow up, treatment failure, death, transfer, and still on treatment.

Secondary outcomes

  1. 12-month relapse-free survival

    Time frame: From completion of prescribed treatment to death or TB recurrence, up to 12 months

    Length of time after treatment ends that the patient survives without TB recurrence

  2. Exposure time to ineffective drugs

    Time frame: At the anticipated completion of prescribed treatment, up to 18 months

    Cumulative length of time on individual drugs to which Mtb is found to be resistant, per participant

  3. Number of participants with acquired drug resistance

    Time frame: At the anticipated completion of prescribed treatment, up to 18 months

    Number of participants with M.tuberculosis acquiring additional drug resistance during treatment

  4. Time to effective treatment initiation with three drugs

    Time frame: From diagnosis to treatment initiation with at least three effective drugs, up to 18 months

    Length of time from diagnosis to treatment initiation with at least three effective drugs to which M.tuberculosis is susceptible

  5. Time to effective treatment initiation with four drugs

    Time frame: From diagnosis to treatment initiation with at least four effective drugs, up to 18 months

    Length of time from diagnosis to treatment initiation with at least four effective drugs to which M.tuberculosis is susceptible

  6. Time to culture conversion

    Time frame: From diagnosis to stable culture conversion, up to 9 months

    Length of time from diagnosis to stable culture conversion, defined as the first of two (consecutive or non-consecutive) negative sputum cultures without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs of active TB, up to 9 months

Other outcomes

  1. Number of participants with clinical uptake of sequencing intervention results

    Time frame: At the anticipated completion of prescribed treatment, up to 18 months

    The number of sequencing intervention results with treatment regimen adjustment where appropriate treatment change is indicated

  2. Cost-effectiveness of the sequencing intervention

    Time frame: At the anticipated completion of prescribed treatment, up to 18 months

    Costs of necessary personnel, consumables, facility, logistics, and per unit tests

Study contacts

Contact information is provided by the study sponsor or research team.

John Z Metcalfe, MD, PhD

CONTACT

[email protected]

+14152068314

Rob Warren, PhD

CONTACT

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Find
  • National Health Laboratory Service (NHLS), South Africa
  • National Institute for Communicable Diseases, South Africa
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Translational Genomics Research Institute
  • University Hospital Heidelberg
  • University of Stellenbosch

Registry information

Official study title

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

Acronym: TSELiOT

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 23, 2022
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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