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

NCT06590428 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

  • Rifampin-resistant Tuberculosis
  • Drug-resistant Tuberculosis

Interventions

OTHER

Therapeutic Drug Monitoring for Linezolid

TDM with dose adjustment for trough concentration \>2.5 mg/L LZD

Sponsors & Collaborators

  • University of Cape Town

    collaborator OTHER

  • St George's, University of London

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • National Department of Health, South Africa

    collaborator UNKNOWN

  • Columbia University

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • James CM Brust, MD · Albert Einstein College of Medicine

  • Gary Maartens, MBChB · University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-07
Primary Completion
2029-06-30
Completion
2029-12-31

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 NCT06590428 on ClinicalTrials.gov