Actively Recruiting
Therapeutic Drug Monitoring for Linezolid in the Treatment of Rifampin-resistant Tuberculosis
Led by Albert Einstein College of Medicine · Updated on 2026-05-04
280
Participants Needed
1
Research Sites
190 weeks
Total Duration
On this page
Sponsors
A
Albert Einstein College of Medicine
Lead Sponsor
U
University of Cape Town
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Therapeutic Drug Monitoring for Linezolid in the Treatment of Rifampin-resistant Tuberculosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male or female patient over 18 years of age
- Microbiological confirmation of rifampicin-resistant tuberculosis
- Started rifampicin-resistant tuberculosis treatment with Linezolid within 14 days before randomization
- Known and confirmed HIV status; if unknown, must agree to HIV testing at enrollment
You will not qualify if you...
- Severe medical condition expected to cause death within 7 days
- Pregnant at time of screening
- Initial Linezolid dose less than 600 mg daily
- Severe extrapulmonary tuberculosis (meningitis, pericarditis, or osteomyelitis)
- Unlikely to attend follow-up visits at Nkqubela Hospital due to residence location
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nkqubela TB Specialist Hospital
East London, Eastern Cape, South Africa, 5206
Actively Recruiting
Research Team
J
James CM Brust, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here