RecruitingNot ApplicableNCT06590428

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


Sponsor

Albert Einstein College of Medicine

Enrollment

280 participants

Start Date

Apr 7, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using drug-level monitoring (called therapeutic drug monitoring) to help personalize the dose of linezolid — an antibiotic used to treat drug-resistant tuberculosis (TB), including rifampicin-resistant TB (RR-TB) and multi-drug resistant TB (MDR-TB). Linezolid can be effective but also has side effects at certain doses. **You may be eligible if...** - You are over 18 years old - You have confirmed rifampicin-resistant tuberculosis (by lab testing) - You started a TB treatment regimen containing linezolid no more than 14 days before enrollment - Your HIV status is known (both HIV-positive and HIV-negative patients can join; if unknown, testing must be done) **You may NOT be eligible if...** - You have a serious unstable medical condition that would interfere with study participation - You are pregnant at the time of screening - You are taking less than 600 mg of linezolid daily 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

OTHERTherapeutic Drug Monitoring for Linezolid

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


Locations(1)

Nkqubela TB Specialist Hospital

East London, Eastern Cape, South Africa

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NCT06590428


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