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Therapeutic Drug Monitoring for Linezolid in the Treatment of Rifampin-resistant Tuberculosis

Study acronym: THERMOL
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Start date changed from estimate of Mar 2026 to Apr 7, 2026
    • Eligibility criteria shortened, about 17 words
    • Secondary endpoints: 3 to 5
    v8
  2. Trial status: Not Yet Recruiting to Recruitingv7 Show 4 more changesShow less
    • Start date: Dec 2025 to Mar 2026
    • Primary completion date: Mar 1, 2029 to Jun 2029
    • Study completion date: Sep 1, 2029 to Dec 2029
    • Site details revised
  3. Primary completion date: May 2029 to Mar 1, 2029
    • Study completion date: Nov 2029 to Sep 1, 2029
    v6
  4. Primary completion date: Jun 2029 to May 2029
    • Study completion date: Dec 2029 to Nov 2029
    v5
  5. Start date: Sep 2025 to Dec 2025
    • Primary completion date: Mar 2029 to Jun 2029
    • Study completion date: Sep 2029 to Dec 2029
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: May 2028 to Mar 2029
    • Start date: Nov 2024 to Sep 2025
    • Study completion date: Nov 2028 to Sep 2029
    • Collaborators: 4 to 6
    v3
  2. Primary completion date: Apr 2028 to May 2028
    • Study completion date: Oct 2028 to Nov 2028
    • Start date: Oct 2024 to Nov 2024
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is a two-arm, pragmatic, open-label, randomized clinical trial to determine the efficacy of Therapeutic Drug Monitoring (TDM) in preventing premature discontinuation of Linezolid (LZD) in participants with Rifampicin-resistant tuberculosis (RR-TB). Following the initiation of treatment, participants will be monitored throughout the approximate 6-month duration of RR-TB therapy.
Trial Details
NCT Number NCT06590428
Lead Sponsor Albert Einstein College of Medicine
Collaborators: University of Cape Town, St George's, University of London, Emory University, National Department of Health, South Africa, Columbia University, National Institute of Allergy and Infectious Diseases (NIAID)
Conditions
(from sponsor)		 Rifampin-resistant Tuberculosis, Drug-resistant Tuberculosis
Related terms Tuberculosis, Multidrug-Resistant
Enrollment 280 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov