Overview
This is a Phase 3, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-ZID vs. meropenem in the treatment of hospitalized adults with cUTI or AP.
Approximately 528 hospitalized adult subjects (≥ 18 years of age) diagnosed with cUTI or AP will be enrolled in the study. The diagnosis of cUTI or AP will be based on a combination of clinical symptoms and signs plus the presence of pyuria. The total duration of treatment with study drug is 7 to 10 days. Each subject must remain hospitalized during the study drug treatment period; no outpatient parenteral antibiotic therapy is allowed.
Eligibility
Inclusion Criteria:
- Male or female ≥ 18 years of age
- Provide a signed written informed consent prior to any study-specific procedures
- Meet the clinical criteria for either cUTI or AP
- Requires hospitalization to manage the cUTI or AP
- Agrees to use effective methods of contraception
Exclusion Criteria:
- Known or suspected disease that may confound the assessment of efficacy.
- Receipt of more than 72 hours of prior antibiotic therapy except for those failing prior antibiotic therapy and/or having documented uropathogen resistant to the prior therapy.
- Rapidly progressive illness such that the subject is unlikely to survive the study period.
- Pregnant or breastfeeding women
- History of a seizure disorder requiring current treatment
- Creatinine clearance < 15 mL/min or on renal dialysis
- Neutropenia or elevated liver enzymes
- Hypersensitivity to beta-lactam antibiotics
- Unlikely to comply with the protocol or the Investigator considers that study participation may not be optimal for the subject