drugset / Trial / NCT06057519

Pragmatic Optimized Rifampicin Trial

NCT06057519

Phase 3 Recruiting 164 enrolled Radboud University Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to compare an optimized dose (1800 mg) of rifampicin to standard dose (450 mg if patient \<50 kg and 600 mg if patient \>50kg) of rifampicin in tuberculosis patients. The main questions it aims to answer are: * To compare the incidence of hepatotoxicity occurs in the optimized dose vs standard dose arm * To compare any adverse events occur in the optimized dose vs standard dose arm * To compare final treatment outcome at the end of treatment according to WHO definitions of cure in the optimized dose regimen versus the standard dose regimen. * To compare two and three months culture conversion rates in the optimized dose regimen versus the standard dose regimen. * To describe and compare the steady-state plasma pharmacokinetics of the optimized dose regimen versus the standard dose regimen. Participants will be given an optimized dose of 1800 mg of rifampicin daily. Researchers will compare the optimized and standard dose to see if more hepatotoxicity occurs.

Timeline

Start
2024-01-16
Primary completion
2026-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Rifampin Small molecule 450 mg
Subject Rifampin Small molecule 600 mg
Subject Rifampin Small molecule 1800 mg