A Phase IV post marketing safety study of Garenoxacin mesylate in patients with Bacterial Respiratory Tract Infections

Glenmark Pharmaceuticals Ltd0 个研究点目标入组 461 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. Male or female subjects, age more than or equal to 18 and less than or equal to 65 years at the time of informed consent.
•2. Subjects with clinical signs and symptoms of respiratory tract infections with bacteriological etiology suspected by the Investigator during evaluation in real life clinical settings.
•3. Provide written informed consent.
•4. Willing and able to comply with all aspects of the study protocol.

•Subjects requiring hospitalization
•Subjects with known or suspected hypersensitivity to fluoroquinolones or any constituents of the formulation.
•Subjects who have received antimicrobial therapy within 7 days prior to enrollment
•Pneumonia acquired in hospital within past 14 days
•Patients with severe complications of RTI or history of hospitalization
•An uncontrolled, unstable clinically significant medical condition
•Neutropenia (less than or equal to 500 PMNs/c.mm), thrombocytopenia (less than 100000 per microlitre
•Clinically significant derangements in alanine transaminase (ALT), aspartate transaminase (AST) ,bilirubin or other laboratory parameters
•History of Cardiac arrthymias and CNS disorders
•Pregnant and/or lactating women.

发起方

Glenmark Pharmaceuticals Ltd