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Pragmatic Optimized Rifampicin Trial

ConditionTuberculosis, Pulmonary
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadboud University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

The patient has tuberculosis which is 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Optimised dose rifampicin

    Drug

    Optimized dose of rifampicin

  • Standard dose rifampicin

    Drug

    Standard dose rifampicin

Treatment groups

164 Participants
are divided into 2 treatment groups
Group A: Optimized dose rifampicinExperimental treatment 1 intervention
Group B: Standard dose rifampicinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of hepatotoxicity

How often does hepatotoxicity occur in patients with optimized dose rifampicin vs standard dose rifampicin

Time frame
26 weeks

Secondary outcomes

1

Adverse events

The proportion of adverse events overall and graded by severity assessed to be related or probably related to rifampicin will be compared between treatment arms.

Time frame
26 weeks
2

Treatment outcome

Final treatment outcome at the end of treatment according to WHO definitions of cure will be compared between treatment arms

Time frame
26 weeks
3

Culture conversion rate

Two and three months culture conversion rates will be compared between treatment arms.

Time frame
2 and 3 months post-treatment initiation
4

PK parameter, AUC0-24

Steady-state plasma pharmacokinetic parameters will be compared between treatment arms. The AUC0-24 will be determined using sparse PK sampling.

Time frame
2 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Radboud University Medical Center

Lead sponsor

Source ClinicalTrials.gov
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