Pragmatic trial on the safety and tolerability of an optimized dose of rifampicin in tuberculosis patients
Phase 3
- Conditions
- tuberculosis10028440
- Registration Number
- NL-OMON53704
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
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.
Exclusion Criteria
Patient infected with a rifampicin-resistant strain of M. tuberculosis.
The patient has TB meningitis.
The patient is in a coma.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the incidence of hepatotoxicity, which will be compared<br /><br>between treatment arms at the end of the 6 months treatment. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are:<br /><br>• The proportion of adverse events overall and graded by severity assessed to<br /><br>be related or probably related to rifampicin during the 6 months treatment will<br /><br>be compared between treatment arms.<br /><br>• Final treatment outcome at the end of treatment according to WHO definitions<br /><br>of cure will be compared between treatment arms.<br /><br>• Two and three months culture conversion rates will be compared between<br /><br>treatment arms.<br /><br>• Steady-state plasma pharmacokinetic parameters will be compared between<br /><br>treatment arms.</p><br>