MedTrace Logo

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

NCT04979806 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 530

Last updated 2026-05-22

Study results available
· View outcomes & findings →

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

DRUG

Cefepime-zidebactam (FEP-ZID)

3 g (2 g FEP + 1 g ZID) IV q8h

DRUG

Meropenem

1 g IV q8h

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • Wockhardt

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-28
Primary Completion
2024-11-25
Completion
2024-11-25
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • China
  • Estonia
  • India
  • Lithuania
  • Mexico
  • Poland
  • Slovakia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04979806 on ClinicalTrials.gov