Actively Recruiting
Pragmatic Optimized Rifampicin Trial
Led by Radboud University Medical Center · Updated on 2026-01-21
164
Participants Needed
2
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pragmatic Optimized Rifampicin Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- Female patients of childbearing potential must have a negative serum pregnancy test, and consent to practice an effective method of birth control during the study.
- Female patients must not be lactating during the trial.
- Effective birth control for female patients must include two methods, including methods that the patient's sexual partner(s) use.
- At least one birth control method must be a barrier method.
- Female patients are considered not to be of childbearing potential if they are post-menopausal with no menses for the last 12 months, or surgically sterile (bilateral oophorectomy, hysterectomy, tubal ligation done at least 12 months prior to enrolment).
- The patient will be compliant to the study schedule, as judged by the investigator.
You will not qualify if you...
- The patient has tuberculosis 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.
- Circumstances that raise doubt about free, uncoerced consent to study participation (e.g. prisoner or mentally handicapped).
- The patient is not able to give consent personally.
- Poor general condition or comorbidities where delay in treatment cannot be tolerated or death within three months is likely.
- Concurrent treatment that may interfere with study participation.
- The patient is pregnant or breast-feeding.
- Patient infected with rifampicin-resistant strain of M. tuberculosis.
- Known allergy or intolerance for rifamycins.
- Known or suspected current alcohol, drug, or amphetamine abuse compromising safety or cooperation.
- Allergy, intolerance, or conditions contraindicating rifamycins or standard TB drugs.
- Treatment with any other investigational drug within 1 month prior to enrolment or planned enrolment in other trials within 6 months.
- Laboratory abnormalities at screening: AST and/or ALT >3x upper limit, total bilirubin >2.5x upper limit, or creatinine clearance <30 mls/min.
- Acute, severe, or life-threatening drug-induced liver disease in the past.
- Chronic liver or renal disease.
- The patient has icterus.
- Previous anti-TB treatment ended within last 3 months.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
ASL Città di Torino
Turin, Italy
Actively Recruiting
2
Radboud University Medical Centre
Nijmegen, Netherlands
Actively Recruiting
Research Team
J
Jodie Schilkdraut, PhD
CONTACT
I
Iris Spelier
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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