Therapeutic Drug Monitoring for Linezolid in the Treatment of Rifampin-resistant Tuberculosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlbert Einstein College of Medicine
About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Therapeutic Drug Monitoring for Linezolid
Treatment groups
280 Participants
are divided into 2 treatment groupsSponsors and collaborators
Albert Einstein College of Medicine
Lead sponsor
University of Cape Town
Collaborator
St George's, University of London
Collaborator
Emory University
Collaborator
National Department of Health, South Africa
Collaborator
Columbia University
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov