Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Inclusion Criteria:

1. Male or female ≥ 18 years of age

2. Provide a signed written informed consent prior to any study-specific procedures

3. Meet the clinical criteria for either cUTI or AP

4. Requires hospitalization to manage the cUTI or AP

5. Agrees to use effective methods of contraception

Exclusion Criteria:

1. Known or suspected disease that may confound the assessment of efficacy.

2. Receipt of more than 72 hours of prior antibiotic therapy except for those failingprior antibiotic therapy and/or having documented uropathogen resistant to the priortherapy.

3. Rapidly progressive illness such that the subject is unlikely to survive the studyperiod.

4. Pregnant or breastfeeding women

5. History of a seizure disorder requiring current treatment

6. Creatinine clearance < 15 mL/min or on renal dialysis

7. Neutropenia or elevated liver enzymes

8. Hypersensitivity to beta-lactam antibiotics

9. Unlikely to comply with the protocol or the Investigator considers that studyparticipation may not be optimal for the subject