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
Mar 1, 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
Inclusion Criteria7
- Adult male or female patient \> 18 years of age
- Microbiological confirmation of rifampicin-resistant tuberculosis (e.g., phenotypic drug susceptibility testing, GeneXpert MTB/RIF™). Participants may have resistance to additional medications as well - i.e., MDR and XDR TB - but must have resistance to at least rifampin
- Initiated on a RR-TB treatment regimen containing linezolid, no more than 14 days prior to enrollment
- HIV status is known
- Both HIV-positive and HIV-negative individuals are eligible
- If an individual reports unknown HIV results, they must consent to HIV testing at time of enrollment to confirm status. If they decline to be tested, they are not eligible for the study
- If an individual declines to share his or her HIV status, they are not eligible for the study. Patients reporting unknown HIV status will be required to have had confirmatory testing within 6 months of study screening
Exclusion Criteria3
- Current unstable or uncontrolled major medical comorbidity that would interfere with subject's ability to participate in the study
- Pregnant at time of screening
- Initial linezolid dose \< 600mg daily
Interventions
OTHERTherapeutic Drug Monitoring for Linezolid
TDM with dose adjustment for trough concentration \>2.5 mg/L LZD
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06590428