NCT06590428 Therapeutic Drug Monitoring for Linezolid in the Treatment of Rifampin-resistant Tuberculosis
| NCT ID | NCT06590428 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Albert Einstein College of Medicine |
| Condition | Rifampin-resistant Tuberculosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2026-04-07 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 280 participants in total. It began in 2026-04-07 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
James CM Brust, MD
PRINCIPAL INVESTIGATOR
Albert Einstein College of Medicine
Frequently Asked Questions
Who can join the NCT06590428 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rifampin-resistant Tuberculosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06590428 currently recruiting?
Yes, NCT06590428 is actively recruiting participants. Contact the research team at james.brust@einsteinmed.edu for enrollment information.
Where is the NCT06590428 trial being conducted?
This trial is being conducted at East London, South Africa.
Who is sponsoring the NCT06590428 clinical trial?
NCT06590428 is sponsored by Albert Einstein College of Medicine. The principal investigator is James CM Brust, MD at Albert Einstein College of Medicine. The trial plans to enroll 280 participants.