Tuberculosis, PulmonaryPhase 3PORTNCT06057519
Pragmatic Optimized Rifampicin Trial
A Phase 3 study testing Optimised dose rifampicin and Standard dose rifampicin in people with Tuberculosis, Pulmonary, run by Radboud University Medical Center at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Pulmonary
- What is being tested?
- Optimised dose rifampicin and Standard dose rifampicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Jan 2024to 31 Dec 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Female patients of childbearing potential must have a negative serum pregnancy test, and consent to practice an effective method of birth control during the study. And they should not be lactating during the trial (female participants of childbearing potential only). Effective birth control for female patients has to include two methods, including methods that the patient's sexual partner(s) use. At least one must be a barrier method. Female patients are considered not to be of childbearing potential if they are post-menopausal with no menses for the last 12 months, or surgically sterile (this condition is fulfilled by bilateral oophorectomy, hysterectomy, and by tubal ligation which is done at least 12 months prior to enrolment).
- The patient will be compliant to the study schedule, in the discretion of the investigator.
Who cannot join
- 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.
- Circumstances that raise doubt about free, uncoerced consent to study participation (e.g. in a prisoner or mentally handicapped person)
- The patient is not able to give consent personally.
Show all 21Show fewer
- Poor general condition or comorbidities where delay in treatment cannot be tolerated or death within three months is likely. Or if there is concurrent treatment that may interfere.
- The patient is pregnant or breast-feeding.
- Patient infected with a rifampicin-resistant strain of M. tuberculosis.
- Known allergy or intolerance for rifamycins.
- The participant has a known or suspected, current alcohol or drug or amphetamine abuse, that is, in the opinion of the investigator, sufficient to compromise the safety or cooperation of the patient.
- The patient has a known allergy or intolerance, or concomitant disorders or conditions for which rifamycins or other standard TB treatment drugs are contraindicated.
- The patient has had treatment with any other investigational drug within 1 month prior to enrolment, or enrolment into other clinical (intervention) trials is planned in the upcoming 6 months
- Laboratory: at screening one or more of the following abnormalities were observed for the patient in screening laboratory:
- Serum amino aspartate transferase (AST) and/or serum alanine aminotransferase (ALT) activity >3x the upper limit of normal
- Serum total bilirubin level >2.5 times the upper limit of normal
- Creatinine clearance (CrCl) level lower than 30 mls/min
- Acute or severe or life-threatening liver disease induced by drugs in the past
- The patient has a chronic disorder such as liver disease or renal disease.
- The patient has icterus.
- Previous anti-TB treatment: the patient ended a previous TB treatment (episode) within last 3 months.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Medical Centre
Nijmegen
Jodie Schildkraut, Dr.
About this study
Official title: Pragmatic Trial on the Safety and Tolerability of an Optimized Dose of Rifampicin in Tuberculosis Patients
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:
Read more
- 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
- Being tested
- Optimised dose rifampicin, Standard dose rifampicin
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimised dose rifampicinDrug
Optimized dose of rifampicin
Standard dose rifampicinDrug
Standard dose rifampicin
| Study group | Role | What they receive |
|---|---|---|
| Optimized dose rifampicin | Experimental | 1800 mg flat dose Receives: Drug: Optimised dose rifampicin |
| Standard dose rifampicin | Active comparator | 450 mg for patients under 50 kg and 600 mg for patients over 50 kg Receives: Drug: Standard dose rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hepatotoxicity
How often does hepatotoxicity occur in patients with optimized dose rifampicin vs standard dose rifampicin
Measured: 26 weeks
Secondary outcomes (9)
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.
Measured: 26 weeks
Treatment outcome
Final treatment outcome at the end of treatment according to WHO definitions of cure will be compared between treatment arms
Measured: 26 weeks
Culture conversion rate
Two and three months culture conversion rates will be compared between treatment arms.
Measured: 2 and 3 months post-treatment initiation
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.
Measured: 2 Weeks
PK parameter, Cmax
Steady-state plasma pharmacokinetic parameters will be compared between treatment arms. The maximum concentration will be determined using sparse PK sampling.
Measured: 2 Weeks
PK parameter, Tmax
Steady-state plasma pharmacokinetic parameters will be compared between treatment arms. The time to maximum concentration will be determined using sparse PK sampling.
Measured: 2 Weeks
PK parameter, Clearance
Steady-state plasma pharmacokinetic parameters will be compared between treatment arms. The clearance of rifampicin will be determined using sparse PK sampling.
Measured: 2 Weeks
PK parameter, Volume of distribution
Steady-state plasma pharmacokinetic parameters will be compared between treatment arms. The volume of distribution of rifampicin will be determined using sparse PK sampling.
Measured: 2 Weeks
PK parameter, T1/2
Steady-state plasma pharmacokinetic parameters will be compared between treatment arms. The half life of rifampicin will be determined using sparse PK sampling.
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start16 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Boeree, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057519
- Sponsor's protocol ID
- PORT- 01
- Acronym
- PORT
- Status last verified
- Jan 2025
- First submitted
- 7 Aug 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No