Pragmatic trial on the safety and tolerability of an optimized dose of rifampicin in tuberculosis patients

Trial details

Who runs it

IRCCS Ospedale Sacro Cuore Don Calabria

Trial code

EU 2023-509885-39-00

Record updated

2026. augusztus 11.

Original description

The primary endpoint is to assess the safety of a higher dose of rifampicin assessed by the incidence of hepatotoxicity compared between treatment arms at the end of the 6 months treatmentRead full original descriptionShow less

The primary endpoint is to assess the safety of a higher dose of rifampicin assessed by the incidence of hepatotoxicity compared between treatment arms at the end of the 6 months treatment

Inclusion: 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 lactacting during the trial (female participants of childbearing potential only); The patient will be compliant to the study schedule, in the discretion of the investigator; For France only: the patient is affiliated to a social security system (as beneficiary) or has state medical aid (Aide Médical d’Etat, AME) or has an ongoing demand for state medical aid (AME) or has an ongoing demand for an emergency medical care (dispositif de soins d'urgence, as applicable for tuberculosis).

Exclusion: 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; Previous anti‐TB treatment: the patient ended a previous TB treatment (episode) within last 3 months; 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 has tuberculosis which is assessed to receive high dose rifampicin according to national guidelines; Known allergy or intolerance for rifamycins; 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; Patient infected with a rifampicin-resistant strain of M. tuberculosis; 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; The patient has icterus; 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; The patient is pregnant or breast-feeding.

EU CTIS 2023-509885-39-00