Efficacy and safety of Colistin plus high dose ampicillin/sulbactam vs. colistin monotherapy for the treatment of carbapenem resistant Acinetobacter baumannii (CRAB) bacteremia: a multicenter, open-label, randomized controlled trial

Seoul National University Bundang Hospital0 个研究点目标入组 72 人开始时间: 待定最近更新: 2024年5月27日

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•1) Patients who has signed a consent
•: If the patients is unable to provide the consent due to medical conditions, the patient's representative may provide the consent on behalf of the patient if permitted by local law and the standard work instructions.
•2) An adult male or female aged 19 years or older as of the date of written consent
•3) Patients who were confirmed Acinetobacter baumannii bacteremia by blood cultures using using peripheral blood or central venous blood before 96 hours of randomization.

•1) Patients with baceremia of other than Acinetobacter baumanii within 7 days
•2) Patients who has been identified with bacteremia of multiple strains
•3) Patients who has been treated for CRAB infection within 14 days
•4) Paitents who has previously had a significant hypersensitivity to colistin or ampicillin/sulbactam
•5) Patients who had received another clinical trial drug within 28 days
•6) Patients who administred CRAB susceptible antibiotics including colistin for more than 72 hours immediately before taking the clinical trial drug,
•7) Patients with pregnant or breast-feeding
•8) Patients who are expected to die within 2 days after randomization by the investigator
•9) Patients deemed unsuitable for participation in this clinical trial based on the medical opinion of the investigator

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