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Study identifier: NCT06057519 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Pragmatic Optimized Rifampicin Trial

Condition: Tuberculosis, Pulmonary  ·  Sponsor: Radboud University Medical Center

PhasePhase 3
Planned participants164
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Jodie Schilkdraut, PhD  ·  +31 629677680  ·  Jodie.schildkraut@radboudumc.nl

Iris Spelier  ·  +31 650000985  ·  Iris.spelier@radboudumc.nl

Always discuss trial participation with your own doctor first.

Locations (2)

ASL Città di TorinoTurin, ItalyRecruiting
Radboud University Medical CentreNijmegen, NetherlandsRecruiting

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Source record: clinicaltrials.gov/study/NCT06057519