A comparative multicentric study to assess the efficacy and safety of Faropenem sodium extended release (ER) tablets in comparison to Faropenem sodium conventional tablets in patients suffering from respiratory tract infections (RTI) - extended release (ER).respiratory tract infections (RTI)

Cadila Healthcare Ltd0 个研究点目标入组 200 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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•1.Patients between 18-65 years of age.
•2.Patients with established infection of the upper or lower respiratory tract (e.g. acute bacterial exacerbation of chronic bronchitis, acute sinusitis and/or community acquired pneumonia)
•3.Informed consent of the patient/relative.

•1.Pregnancy/Lactation/Less than 18 years of age.
•2.Grossly abnormal liver or kidney function tests or significant hematological abnormalities.
•3.History of known hypersensitivity to any of the penems, penicillincs, cephalosporins or other beta-lactams.
•4.Patients with CNS disorders or epilepsy or history of other factors that can predispose to seizures.
•5.Patients with serious infections requiring hospitalization or life-threatening in nature where monotherapy with Faropenem sodium would be considered inadequate.
•6.Patients receiving any other antibiotic/antibacterial agent in the previous 2/3 days prior to enrolment in the study.
•7.Patients with any other serious concurrent illness or malignancy.
•8.Patients with continuing history of alcohol and / or drug abuse.
•9.Participation in another clinical trial in the past 3 months.

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