Rifampicin for Tuberculosis

Inclusion criteria

• {"criterion_text":"- The patient has provided informed consent for study participation prior to all trial-related procedures.\n- The patient has a diagnosis of pulmonary tuberculosis according to the local diagnostic criteria.\n- The patient is aged 18 years or older at the day of informed consent.\n- No known allergic reactions or toxicity to rifampicin in the past.\n- 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).\n- The patient will be compliant to the study schedule, in the discretion of the investigator.\n- 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 criteria

• {"criterion_text":"- The patient has tuberculosis which is assessed to receive high dose rifampicin according to national guidelines.\n- Known allergy or intolerance for rifamycins.\n- 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.\n- The patient has a known allergy or intolerance, or concomitant disorders or conditions for which rifamycins or other standard TB treatment drugs are contraindicated.\n- 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.\n- 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\n- Acute or severe or life-threatening liver disease induced by drugs in the past\n- The patient has a chronic disorder such as liver disease or renal disease.\n- The patient has icterus.\n- Previous anti‐TB treatment: the patient ended a previous TB treatment (episode) within last 3 months.\n- The patient started current TB treatment more than 4 weeks ago.\n- The patient has TB meningitis.\n- The patient is in a coma.\n- Circumstances that raise doubt about free, uncoerced consent to study participation (e.g. in a prisoner or mentally handicapped person).\n- The patient is not able to give consent personally.\n- 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.\n- The patient is pregnant or breast-feeding.\n- Patient infected with a rifampicin-resistant strain of M. tuberculosis."}

Primary endpoints

• {"endpoint_text":"- The incidence of hepatotoxicity","definition_or_measurement_approach":"Assessed by the incidence of hepatotoxicity compared between treatment arms at the end of the 6 months treatment (safety of higher dose of rifampicin)."}

Secondary endpoints

• {"endpoint_text":"- The proportion of adverse events overall and graded by severity assessed to be related or probably related to rifampicin.","definition_or_measurement_approach":"Proportion of adverse events overall and graded by severity assessed to be related or probably related to rifampicin during the 6 months treatment compared between treatment arms."}
• {"endpoint_text":"- Final treatment outcome at the end of treatment according to WHO definitions of cure.","definition_or_measurement_approach":"Final treatment outcome at the end of treatment compared between treatment arms using WHO definitions of cure."}
• {"endpoint_text":"- Two and three months culture conversion rates","definition_or_measurement_approach":"Culture conversion rates at two and three months compared between treatment arms."}
• {"endpoint_text":"- Steady-state plasma pharmacokinetic parameters","definition_or_measurement_approach":"Comparison of steady-state plasma pharmacokinetic parameters between treatment arms."}

Denmark

Earliest CTIS Part Ii Submission Date

15-12-2023

Latest Decision Or Authorization Date

11-01-2024

Processing Time Days

27

Number Of Sites

1

Number Of Participants

25

Netherlands

Earliest CTIS Part Ii Submission Date

15-12-2023

Latest Decision Or Authorization Date

11-01-2024

Processing Time Days

27

Number Of Sites

1

Number Of Participants

30

Italy

Earliest CTIS Part Ii Submission Date

30-07-2024

Latest Decision Or Authorization Date

12-08-2024

Processing Time Days

13

Number Of Sites

6

Number Of Participants

75

Primary sponsor

Full Name

Stichting Radboud University Medical Center

Organisation Type

Patient organisation/association

Country Of Registered Address

Netherlands