Pragmatic Trial on the Safety and Tolerability of an Optimized Dose of Rifampicin in Tuberculosis Patients
The goal of this clinical trial is to compare an optimized dose (1800 mg) of rifampicin to standard dose (450 mg if patient \<50 kg and 600 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. * To compare two and three months culture conversion rates in the optimized dose regimen versus the standard dose regimen. * To describe and compare the steady-state plasma pharmacokinetics of the optimized dose regimen versus the standard dose regimen. Participants will be given an optimized dose of 1800 mg of rifampicin daily. Researchers will compare the optimized and standard dose to see if more hepatotoxicity occurs.
• 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.