NCT06590428Recruiting
Therapeutic Drug Monitoring for Linezolid in the Treatment of Rifampin-resistant Tuberculosis
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- First submitted
- 9 Sept 2024
- Start date
- 7 Apr 2026
- Primary completion date
- Jun 2029
- Lead sponsor
- Albert Einstein College of Medicine
- Diseases
- Tuberculosis
- NCT number
- NCT06590428
What you commit to
- Study type: Interventional
- Planned participants: 280
- From 7 Apr 2026 to the primary completion date, Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe medical condition with expected death in the next 7 days
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nkqubela TB Specialist Hospital Coordinator of this site? Confirm its status | East London | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.