Pragmatic Optimized Rifampicin Trial
Recruiting
Phase 3
Interventional Study
Tuberculosis, Pulmonary
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 164 (estimated)
- Sponsor
- Radboud University Medical Center · Other
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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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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.
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Contacts