Clinical Trial

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

Study acronym: THERMOL
Recruiting
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Summary
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2024-09-09; most recent amendment 2026-04-28.
Status change: Not Yet Recruiting → Recruiting 2026-01-22
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 Rifampin-resistant Tuberculosis, Drug-resistant Tuberculosis
Enrollment 280 participants
Start Date 2026-04-07
Primary Completion 2029-06 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-04