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Pragmatic Optimized Rifampicin Trial

Study acronym: PORT
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026
    • Study sites: 1 to 2
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 1, 2023 to Jan 16, 2024
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06057519
Lead Sponsor Radboud University Medical Center
Conditions
(from sponsor)		 Tuberculosis, Pulmonary
Related terms Tuberculosis, Pulmonary
Enrollment 164 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov