A Phase 3 study of an Investigational Drug, Cefepime-zidebactam versus Meropenem in patients with Complicated Urinary Tract Infection or Acute Pyelonephritis

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

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002768-28-BG

Enrollment

528

Registered

2021-12-10

Start date

2022-03-11

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complicated urinary tract infection or acute pyelonephritis MedDRA version: 21.0 Level: LLT Classification code 10080628 Term: Complicated urinary tract infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.1 Level: LLT Classification code 10001032 Term: Acute pyelonephritis System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: Cefepime-zidebactam Product Code: WCK 5222 (FEP-ZID) Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: CEFEPIME HYDROCHLORIDE CAS Number: 123171-59-5 Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female 18 years or older 2. Able to provide signed informed consent 3. Have a diagnosis of complicated urinary tract infection (cUTI) or acute pyelonephritis (AP) 4. Have evidence of pyuria 5. If available, have a Gram-negative pathogen susceptible to meropenem cultured from the urine 5. Requires hospitalization to manage the cUTI or AP 6. Agree to use effective methods of contraception Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 128

Exclusion criteria

Exclusion criteria: 1. Know or suspected disease that may confound the assessment of efficacy. 2. Receipt of more than 72 hours of prior antibiotic therapy except for those failing prior antibiotic therapy 3. Rapidly progressive illness such that the subject is unlikely to survive the study period. 4. Pregnant or breastfeeding females 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 study participation may not be optimal for the subject.

Design outcomes

Primary

Measure	Time frame
Main Objective: • To demonstrate that cefepime-zidebactam (FEP-ZID) is non-inferior to meropenem in overall success (clinical cure and microbiological eradication) in the microbiological Modified Intent-to-treat (mMITT) population at the Test-of-Cure (TOC) visit • To assess the overall safety and tolerability of FEP-ZID in the Safety population;Secondary Objective: • To evaluate the overall outcome at TOC in the Clinically Evaluable (CE) and Microbiological Evaluable (ME) populations • To evaluate the overall outcome at End-of-Treatment (EOT) in the mMITT population • To evaluate the clinical outcomes at EOT (mMITT population) and at TOC (mMITT, CE and ME populations) • To evaluate the microbiological outcome at EOT (mMITT population) and TOC (mMITT, CE and ME populations) • To evaluate the by-pathogen overall outcome (mMITT, CE and ME populations) as well as by-pathogen clinical (mMITT and CE populations) and microbiological outcomes (mMITT and ME populations) at TOC • To evaluate the clinical outcome at Late Follow-Up (LFU) in the mMITT population • To evaluate the pharmacokinetics (PK) of FEP-ZID in adult subjects with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP) ;Primary end point(s): 1. Overall Outcome at TOC - Overall Success: clinical cure and microbiological eradication - Overall Failure: clinical failure or microbiological persistence ( - Overall Indeterminate: Study data are missing for evaluation of efficacy or microbiological outcome for any reason, and the subject cannot otherwise be declared an overall failure at TOC 2. Evaluation of safety based on adverse events, clinical laboratory evaluations, vital signs, electrocardiograms collected during the study. ;Timepoint(s) of evaluation of this end point: The primary outcome at TOC is determined at Study Day 17	—

Measure

Time frame

Main Objective: • To demonstrate that cefepime-zidebactam (FEP-ZID) is non-inferior to meropenem in overall success (clinical cure and microbiological eradication) in the microbiological Modified Intent-to-treat (mMITT) population at the Test-of-Cure (TOC) visit • To assess the overall safety and tolerability of FEP-ZID in the Safety population;Secondary Objective: • To evaluate the overall outcome at TOC in the Clinically Evaluable (CE) and Microbiological Evaluable (ME) populations • To evaluate the overall outcome at End-of-Treatment (EOT) in the mMITT population • To evaluate the clinical outcomes at EOT (mMITT population) and at TOC (mMITT, CE and ME populations) • To evaluate the microbiological outcome at EOT (mMITT population) and TOC (mMITT, CE and ME populations) • To evaluate the by-pathogen overall outcome (mMITT, CE and ME populations) as well as by-pathogen clinical (mMITT and CE populations) and microbiological outcomes (mMITT and ME populations) at TOC • To evaluate the clinical outcome at Late Follow-Up (LFU) in the mMITT population • To evaluate the pharmacokinetics (PK) of FEP-ZID in adult subjects with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP) ;Primary end point(s): 1. Overall Outcome at TOC - Overall Success: clinical cure and microbiological eradication - Overall Failure: clinical failure or microbiological persistence ( - Overall Indeterminate: Study data are missing for evaluation of efficacy or microbiological outcome for any reason, and the subject cannot otherwise be declared an overall failure at TOC 2. Evaluation of safety based on adverse events, clinical laboratory evaluations, vital signs, electrocardiograms collected during the study. ;Timepoint(s) of evaluation of this end point: The primary outcome at TOC is determined at Study Day 17

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Secondary

Measure	Time frame
Secondary end point(s): 1. Overall outcome at End-of-Treatment (EOT) 2. Clinical outcomes at EOT 3. Microbiological outcome at EOT 4. By-pathogen overall outcome as well as by-pathogen clinical and microbiological outcomes at TOC 5. Clinical outcome at Late Follow-Up 6. To evaluate the pharmacokinetics (PK) of FEP-ZID in the study population ;Timepoint(s) of evaluation of this end point: Outcome timepoint is determined by study treatment days, ToC visit (Day 17) and clinical outcome at LFU (day 26)	—

Measure

Time frame

Secondary end point(s): 1. Overall outcome at End-of-Treatment (EOT) 2. Clinical outcomes at EOT 3. Microbiological outcome at EOT 4. By-pathogen overall outcome as well as by-pathogen clinical and microbiological outcomes at TOC 5. Clinical outcome at Late Follow-Up 6. To evaluate the pharmacokinetics (PK) of FEP-ZID in the study population ;Timepoint(s) of evaluation of this end point: Outcome timepoint is determined by study treatment days, ToC visit (Day 17) and clinical outcome at LFU (day 26)

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Countries

Belarus, Bulgaria, China, Estonia, India, Lithuania, Mexico, Peru, Poland, Slovakia, United States

Contacts

Public ContactWojciech Gutman

Medpace Inc

w.gutman@medpace.com+482237012702481

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026