NCT04979806

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

A Phase 3, Randomized, Double-blind, Multicenter, Comparative Study to Determine the Efficacy and Safety of Cefepime-zidebactam vs. Meropenem in the Treatment of Complicated Urinary Tract Infection or Acute Pyelonephritis in Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 530 (actual)
• Sponsor: Wockhardt · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Complicated Urinary Tract Infection
• Acute Pyelonephritis

Interventions

Type	Name	Description
DRUG	Cefepime-zidebactam (FEP-ZID)	3 g (2 g FEP + 1 g ZID) IV q8h
DRUG	Meropenem	1 g IV q8h

Timeline

• Start date: 2022-08-28
• Primary completion: 2024-11-25
• Completion: 2024-11-25
• First posted: 2021-07-28
• Last updated: 2025-09-30

Locations

48 sites across 9 countries: United States, Bulgaria, China, Estonia, India, Lithuania, Mexico, Poland, Slovakia

Regulatory

• FDA-regulated drug study