Phase 3
Completed N=530
Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
complicated urinary tract infection · Acute Pyelonephritis
Source: ClinicalTrials.gov NCT04979806 ↗
Enrolled (actual)
530
Serious AEs
1.7%
Results posted
May 2026
Primary outcomePrimary: Percentage of Subjects With Overall Success at Test-of-Cure — 250; 93; 31; 43 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Overall Success at Test-of-Cure |
250; 93; 31; 43 | — |
| PRIMARY Percentage of Subjects With Treatment-Emergent Adverse Events (TEAE) |
112; 50 | — |
| SECONDARY Percentage of Subjects With Overall Success at End-of-Treatment |
270; 132; 11; 4 | — |
| SECONDARY Percentage of Subjects With Clinical Cure at End-of-Treatment |
274; 133; 7; 3 | — |
| SECONDARY Percent of Subjects With Microbiological Eradication at End-of-Treatment |
276; 134; 5; 2 | — |
| SECONDARY Percentage of Subjects With Clinical Cure at Test-of-Cure |
272; 129; 9; 7 | — |
| SECONDARY Percent of Subjects With Microbiological Eradication at Test-of-Cure |
256; 96; 25; 40 | — |
| SECONDARY Percentage of Subjects With Clinical Cure at Late Follow-up |
264; 128; 8; 1 | — |
| SECONDARY Plasma Concentration of FEP-ZID |
89.400; 44.941; 47.375; 24.461; 19.297; 10.250 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04979806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.