Pragmatic Optimized Rifampicin Trial
ConditionTuberculosis, Pulmonary
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadboud University Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
The patient has provided informed consent for study participation prior to all trial-related procedures.
The patient has a diagnosis of pulmonary tuberculosis according to the local diagnostic criteria.
The patient is aged 18 years or older at the day of informed consent.
No known allergic reactions or toxicity to rifampicin in the past.
Disqualifiers
The patient has tuberculosis which is assessed to receive high dose rifampicin according to the local standard of care.
The patient started current TB treatment more than 4 weeks ago.
The patient has TB meningitis.
The patient is in a coma.
Trial design
Treatments tested in this trial
- Optimised dose rifampicin
- Standard dose rifampicin
Treatment groups
164 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov