Actively Recruiting
Pragmatic Trial on the Safety and Tolerability of an Optimized Dose of Rifampicin in Tuberculosis Patients
Led by Radboud University Medical Center · Updated on 2026-01-21
164
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an optimized dose of rifampicin compared to the standard dose in adults with pulmonary tuberculosis. This trial aims to compare the incidence of liver toxicity, adverse events, treatment outcomes based on WHO cure definitions, culture conversion rates at two and three months, and pharmacokinetic parameters between the two dosing regimens. The study is a randomized phase 3 clinical trial sponsored by Radboud University Medical Center. Participants will receive either an optimized daily dose of 1800 mg rifampicin or a standard dose based on body weight (450 mg if under 50 kg, 600 mg if over 50 kg). The study compares safety and effectiveness between these two dosing strategies over the treatment period. No placebo is used, and participants are assigned randomly to one of the two dosing groups. During the trial, participants will be monitored for liver toxicity over 26 weeks, with assessments of adverse events and treatment outcomes at the same time. Culture conversion rates will be evaluated at two and three months after treatment initiation. Pharmacokinetic measurements including drug concentration and clearance will be taken at two weeks. Participants will follow a study schedule for visits and laboratory tests to track safety and treatment response throughout the trial.
CONDITIONS
Brief Title
Pragmatic Optimized Rifampicin Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has provided informed consent before trial procedures
- Diagnosed with pulmonary tuberculosis as per local criteria
- Aged 18 years or older at consent
- No known allergic reaction or toxicity to rifampicin
- Female patients of childbearing potential have negative pregnancy test and agree to effective birth control including barrier methods
- Female patients not of childbearing potential if post-menopausal for 12 months or surgically sterile
- Patient will comply with study schedule as judged by investigator
You will not qualify if you...
- Patient assessed to receive high dose rifampicin under local standard care
- Started current TB treatment more than 4 weeks ago
- Has TB meningitis
- Patient is in a coma
- Circumstances raise doubt about free consent (e.g., prisoner, mentally handicapped)
- Unable to give personal consent
- Poor general condition or comorbidities where treatment delay is intolerable or death likely within 3 months
- Pregnant or breastfeeding
- Infected with rifampicin-resistant M. tuberculosis strain
- Known allergy or intolerance to rifamycins
- Known or suspected alcohol, drug, or amphetamine abuse compromising safety or cooperation
- Contraindications to rifamycins or other standard TB drugs
- Received other investigational drugs within 1 month or planned enrollment in other trials within 6 months
- Screening labs show AST or ALT >3x upper limit, total bilirubin >2.5x upper limit, or creatinine clearance under 30 mL/min
- Past acute, severe, or life-threatening drug-induced liver disease
- Chronic liver or renal disease
- Presence of icterus
- Completed previous TB treatment episode within last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 26 weeks
Participants receive either an optimized dose or standard dose of rifampicin for tuberculosis treatment.
Weekly visits for up to 26 weeks
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
I
Iris Spelier
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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