Could a higher dose of rifampicin beat TB faster?
NCT ID NCT06057519
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 164 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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ASL Città di Torino
RECRUITINGTurin, Italy
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Radboud University Medical Centre
RECRUITINGNijmegen, Netherlands
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Other studies related to the condition(s) this trial covers.
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- Can a 4-Month drug cocktail cure TB as well as 6 months?
- Can a 4-Drug combo cut TB treatment time in half?
- Can new drug cocktails shorten TB treatment?
- Can higher doses of TB drugs cut treatment time?
- New rapid test could free TB patients from isolation sooner