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Could a higher dose of rifampicin beat TB faster?

NCT ID NCT06057519

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a higher dose of the antibiotic rifampicin (1800 mg daily) is safe and works better than the standard dose for adults with pulmonary tuberculosis. About 164 participants will be randomly assigned to either the optimized or standard dose. Researchers will monitor liver toxicity, side effects, and cure rates to see if the higher dose improves outcomes without increasing harm.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rifampicin
What this could lead to
If successful, this could lead to a more effective and still safe dosing regimen for tuberculosis, potentially improving cure rates.
What could go wrong
This is a phase 3 trial, but the higher dose may cause more liver toxicity, and results may not apply to all TB patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 164 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASL Città di Torino

    RECRUITING

    Turin, Italy

  • Radboud University Medical Centre

    RECRUITING

    Nijmegen, Netherlands

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