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Pragmatic Optimized Rifampicin Trial

NCT06057519 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2026-01-21

No results posted yet for this study

Summary

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

  • Tuberculosis, Pulmonary

Interventions

DRUG

Optimised dose rifampicin

Optimized dose of rifampicin

DRUG

Standard dose rifampicin

Standard dose rifampicin

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Martin Boeree · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-16
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Italy
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06057519 on ClinicalTrials.gov