Skip to main content
OpenTrials
Completed

NCT Number: NCT04979806

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Complicated Urinary Tract Infection Acute Pyelonephritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

MHAT Dobrich AD, Dobrich, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cefepime-zidebactam (FEP-ZID)

Drug

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

Meropenem

Drug

1 g IV q8h

Primary outcomes

  1. Percentage of Subjects With Overall Success at Test-of-Cure

    Time frame: Test Of Cure Visit (Day 17 ± 2 days)

    Overall success is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to <1000 colony forming units or CFU/mL)

  2. Percentage of Subjects With Treatment-Emergent Adverse Events (TEAE)

    Time frame: Day 1 to the end of study Late Follow-Up visit (LFU) (26 ± 2 days)]

    Collection of number of adverse events.

Secondary outcomes

  1. Percentage of Subjects With Overall Success at End-of-Treatment

    Time frame: End of Treatment Visit (Day 7 - 10 ± 1 day)

    Overall success is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (<1000 CFU/mL)

  2. Percentage of Subjects With Clinical Cure at End-of-Treatment

    Time frame: End of Treatment Visit (Day 7 - 10 ± 1 day)

    Clinical cure is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to <1000 CFU/mL)(CFU)/mL.

  3. Percent of Subjects With Microbiological Eradication at End-of-Treatment

    Time frame: End of Treatment Visit (Day 7 - 10 ± 1 day)

    Microbiologic eradication is defined as demonstrating <1000 CFU/mL of the bacterial pathogen found at study entry

  4. Percentage of Subjects With Clinical Cure at Test-of-Cure

    Time frame: Test-of-Cure (Day 17+-2)

    Clinical cure is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to <1000 CFU/mL)

  5. Percent of Subjects With Microbiological Eradication at Test-of-Cure

    Time frame: Test-of-Cure (Day 17 ± 2 days)

    Microbiologic eradication is defined as demonstrating <1000 CFU/mL of the bacterial

  6. Percentage of Subjects With Clinical Cure at Late Follow-up

    Time frame: Late Follow-up (Day 26 ± 2 days)

    Clinical cure is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to <1000 CFU/mL)

  7. Plasma Concentration of FEP-ZID

    Time frame: On Days 1 and 3 (+1) of dosing prior to infusion, within 15 minutes after the end of infusion, and at 3 timepoints up to 7 hours hours post infusion

    Plasma samples from ZID-FEP-treated subjects were analyzed to determine concentrations of ZID and FEP using a validated assay. Pharmacokinetic analyses were based on the PK populations at pre-specified time points on Days 1 and 3 (+1).

Sponsors and collaborators

Lead sponsor

Wockhardt

Industry

Collaborators

  • Medpace, Inc.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 28, 2021
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.