Health Condition 1: A150- Tuberculosis of lung
Conditions
Interventions
Intervention1: Isoniazid, Rifampin, Pyrazinamide and clofazimine: Once daily isoniazid 300mg, Rifampin 450mg, Pyrazinamide 1200mg and clofazimine 100mg, for 2 months in intensive phase and Isoniazid
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse rateTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactProf Samir Malhotra
PGIMER
Outcome results
None listed