A Phase 3, Multi-Center, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in the Treatment of Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis, in Adults

Meiji Seika Pharma Co., Ltd.0 个研究点目标入组 600 人开始时间: 2023年2月6日最近更新: 2024年9月2日

适应症

试验速览

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•1. Male or female patients = 18 years of age (or age of legal consent, whichever is older) at the time of obtaining informed consent and who can be hospitalized throughout the Treatment Period;
•2. Weight = 140 kg;
•3. Expectation, in the opinion of the Investigator, that the patient’s cUTI or AP will require treatment with at least 5 days of IV antibiotics;
•Complete list of inclusion criteria is in the protocol.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 360
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 240

•1. Has a known imipenem- and/or meropenem-resistant Gram-negative uropathogen (= 105 CFU/mL), isolated from study-qualifying urine culture;
•2. Has known or suspected single or concurrent infection with Acinetobacter species or other organisms that are not adequately covered by the study drug (eg, concurrent viral, mycobacterial, or fungal infection) and needs to be managed with other anti-infectives;
•3. Has only a known Gram-positive primary uropathogen (= 105 CFU/mL), isolated from study qualifying urine culture;
•Complete list of exclusion criteria is in the protocol.

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