Status:
NOT_YET_RECRUITING
Therapeutic Drug Monitoring for Linezolid in the Treatment of Rifampin-resistant Tuberculosis
Lead Sponsor:
Albert Einstein College of Medicine
Collaborating Sponsors:
University of Cape Town
St George's, University of London
Conditions:
Rifampin-resistant Tuberculosis
Drug-resistant Tuberculosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 p...
Detailed Description
Drug-resistant tuberculosis (TB) is a major global epidemic and poses a particular threat to HIV-infected individuals. With limited effective drugs available for treatment, multidrug-, and extensively...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT06590428
Start Date
December 1 2025
End Date
September 1 2029
Last Update
December 4 2025
Active Locations (1)
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1
Nkqubela TB Specialist Hospital
East London, Eastern Cape, South Africa, 5206