Monitoring Linezolid Levels in Rifampin-Resistant Tuberculosis Treatment
Tests blood-level monitoring of linezolid to help adults with drug-resistant tuberculosis keep taking it.
Plain-language title generated from the registry record
Registry title: Therapeutic Drug Monitoring for Linezolid in the Treatment of Rifampin-resistant Tuberculosis
Key facts
- Where
- East London, South AfricaSee the site
Where in South Africa
- Nkqubela TB Specialist HospitalEast London, South AfricaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Albert Einstein College of Medicine
- Trial code
- NCT06590428
- Record updated
- 4 May 2026
- Original description
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.Read full original descriptionShow less
Therapeutic Drug Monitoring for Linezolid in the Treatment of Rifampin-resistant Tuberculosis
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.
Inclusion: Adult male or female patient > 18 years of age; Microbiological confirmation of rifampicin-resistant tuberculosis (e.g., phenotypic or genotypic 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 rifampicin-resistant tuberculosis (RR-TB) treatment regimen containing linezolid, no more than 14 days prior to randomization; HIV status is known and confirmed; Both HIV-positive and HIV-negative individuals are eligible; If an individual reports unknown HIV status, 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.
Exclusion: Severe medical condition with expected death in the next 7 days; Pregnant at time of screening; Initial linezolid dose < 600mg daily; Severe form of extrapulmonary TB (i.e., meningitis, pericarditis, or osteomyelitis); Unlikely to follow-up at Nkqubela Hospital based on location of residence.