NCT06057519

Pragmatic Optimized Rifampicin Trial

Pragmatic Trial on the Safety and Tolerability of an Optimized Dose of Rifampicin in Tuberculosis Patients

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tuberculosis, Pulmonary

Interventions

Type	Name	Description
DRUG	Optimised dose rifampicin	Optimized dose of rifampicin
DRUG	Standard dose rifampicin	Standard dose rifampicin

Timeline

• Start date: 2024-01-16
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-09-28
• Last updated: 2026-01-21

Locations

2 sites across 2 countries: Italy, Netherlands