Evaluation of clofazimine as a part of TB treatment in order to shorten the duration of treatment
- Conditions
- Health Condition 1: A150- Tuberculosis of lung
- Registration Number
- CTRI/2019/03/018102
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Adults with drug-susceptible pulmonary tuberculosis (TB)
- Patients who have not been previously treated for TB or have received less than 7 days of treatment.
- Age more than or equal to 18 years
-Laboratory parameters within normal limits as below:
1.Serum AST and ALT levels less than 3 times the upper limit of normal and total bilirubin less than 2.5 times upper limit of normal
2.Serum creatinine less than 2 times upper limit of normal
3.Hemoglobin equal to or more than 7.0 g/dL
4.Platelet count of at least 50,000/mm3
5.Negative pregnancy test (for women of childbearing potential)
- Willing to give written, informed consent.
- Willing to comply with protocol requirements.
- Confirmed resistance to one or more drugs
- Patients with prolonged QT syndrome or history of prolonged QT syndrome or on treatment with drugs known for QT prolongation
- History of intolerance or allergy to the study medicines
- On treatment with drugs having unacceptable interactions with rifampin
- On antiretroviral drugs
- Pregnancy
-Breast-feeding
- Extrapulmonary disease
- History of participating in any IND study in last 6 months
- History of participating in any non-IND study in the past 3 months
- History of any major illness in past that, in the opinion of the investigators, can interfere with participant safety or study evaluation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse rateTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method Adverse reactions to anti-TB drugs including clofazimineTimepoint: any time of study;Bacteriological cure at the end of treatmentTimepoint: 6 months;Clinical cure at the end of treatmentTimepoint: 6 months;Drug interactions of clofazimineTimepoint: any time of study;The time to sputum culture conversionTimepoint: 2 months