BridgeMD
New treatment option for Tuberculosis, Pulmonary
Official title Pragmatic Optimized Rifampicin Trial
ClinicalTrials.gov ID: NCT06057519
What this study is testing
What is Optimised dose rifampicin?
Optimised dose rifampicin is an investigational medicine, given as an once-daily, being studied as a potential treatment for tuberculosis, pulmonary.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to compare an optimized dose (1800 mg) of rifampicin to standard dose (450 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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.
See the full eligibility 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...
- The patient will be compliant to the study schedule, in the discretion of the investigator.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Turin, Italy
- Nijmegen, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turin, Italy; Nijmegen, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.