Repurposing Clofazimine as part of the first-line anti-TB regimen in order to shorten the overall duration of treatment in patients with susceptible TB - CORTAIL study - CORTAIL study

Indian Council of Medical Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

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