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

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.

Study Overview

• Status: Completed
• Conditions: Acute Pyelonephritis; Complicated Urinary Tract Infection
• Intervention / Treatment: Drug: Cefepime-zidebactam (FEP-ZID); Drug: Meropenem

• Study Type: Interventional
• Enrollment (Actual): 530
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Dobrich, Bulgaria
    • MHAT Dobrich AD
  • Pleven, Bulgaria
    • UMHAT Dr. Georgi Stranski
  • Plovdiv, Bulgaria
    • Multiprofile Hospital for Active Treatment - Plovdiv AD, Plovdiv
  • Rousse, Bulgaria
    • Multiprofile Hospital for Active Treatment - KANEV
  • Silistra, Bulgaria
    • Multiprofile Hospital for Active Treatment (MHAT)- Silistra
  • Sofia, Bulgaria
    • Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
  • Sofia, Bulgaria
    • Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Pirogov
  • Sofia, Bulgaria
    • UMHAT Aleksandrovska Sofia - Clinic of Urology, Clinic of Anaesthesiology and Intensive Care, Clinic of Clinical Hematology
  • Varna, Bulgaria
    • Multiprofile Hospital for Active Treatment (MHAT) Sveta Anna - Varna
• China
  • Changsha, China
    • The Second Xiangya Hospital of Central South University
  • Changsha, China
    • Hunan Provincial People's Hospital
  • Chengdu, China, 610041
    • West China Hospital, Sichuan University
  • Chongqing, China, 400010
    • The Second Affiliated Hospital of Chongqing Medical University
  • Deyang, China
    • Deyang People's Hospital
  • Liaoyang, China
    • General hospital of the PLA northern theater command
  • Shanghai, China, 200040
    • Fudan University Huashan Hospital
  • Shaoxing, China
    • Shaoxing People's Hospital
• Estonia
  • Kohtla-Järve, Estonia
    • Ida-Viru Central Hospital
  • Tallinn, Estonia
    • North Estonia Medical Centre Foundation
  • Tallinn, Estonia
    • West Tallinn Central Hospital
  • Tartu, Estonia
    • Tartu University Hospital
  • Võru, Estonia
    • South-Estonian Hospital Ltd.
• India
  • Ahmedabad, India, 380006
    • Aartham Multi Super Speciality Hospital
  • Aurangabad, India, 431005
    • ORIION Citicare Super Speciality Hospital
  • Maharashtra
    • Aurangabad, Maharashtra, India, 431004
      • Super Speciality Hospital Government Medical College and Hospital
    • Nashik, Maharashtra, India, 422002
      • Supe Hearth & Diabetes Hospital & Research Centre
    • Pune, Maharashtra, India, 411004
      • ACE Hospital and Research Centre
    • Pune, Maharashtra, India, 412105
      • Accord Hospitals
• Lithuania
  • Klaipėda, Lithuania, LT-92288
    • Klaipedos university hospital
  • Vilnius, Lithuania
    • Vilnius University Hospital Santaros Klinikos
  • Vilnius, Lithuania
    • Republican Vilnius University hospital
  • Vilnius, Lithuania
    • Vilnius city clinical hospital
• Mexico
  • Chihuahua City, Mexico, 31238
    • Hospital Angeles Chihuahua
  • Cuernavaca, Mexico, 62290
    • JM Research Cuernavaca
  • Oaxaca City, Mexico
    • Centro de Investigación Clinica de Oaxaca (CICLO)
  • Querétaro, Mexico
    • Pharmacology & Clinical Research
  • Veracruz, Mexico
    • Arke SMO S.A. de C.V.
  • Yucatán, Mexico, C.P 97000
    • Unidad de Atención Médica e Investigación en Salud (Unamis)
• Poland
  • Bolesławiec, Poland
    • Zespol Opieki Zdrowotnej w Boleslawcu
  • Krakow, Poland, 31-559
    • SCM Sp. z o.o.
  • Lodz, Poland, 90-153
    • Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi, Oddzial Nefrologii
  • Warsaw, Poland
    • Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Chorob Wewnetrznych, Nefrologii i Dializoterapii
• Slovakia
  • Banská Bystrica, Slovakia
    • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
  • Nitra, Slovakia
    • Fakultna nemocnica Nitra
  • Poprad, Slovakia
    • Nemocnica Poprad, a.s. Urologicke oddeleni
  • Žilina, Slovakia
    • Fakultna nemocnica s poliklinikou Zilina
• United States
  • Florida
    • Fort Myers, Florida, United States, 33919
      • S&D Clinical Research, LLC
    • Tampa, Florida, United States, 33615
      • Santos Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female ≥ 18 years of age
2. Provide a signed written informed consent prior to any study-specific procedures
3. Meet the clinical criteria for either cUTI or AP
4. Requires hospitalization to manage the cUTI or AP
5. Agrees to use effective methods of contraception

Exclusion Criteria:

1. Known 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 and/or having documented uropathogen resistant to the prior therapy.
3. Rapidly progressive illness such that the subject is unlikely to survive the study period.
4. Pregnant or breastfeeding women
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cefepime-zidebactam (FEP-ZID)	Drug: Cefepime-zidebactam (FEP-ZID); 3 g (2 g FEP + 1 g ZID) IV q8h
Active Comparator: Meropenem	Drug: Meropenem; 1 g IV q8h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Overall Success at Test-of-Cure	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)	Test Of Cure Visit (Day 17 ± 2 days)
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAE)	Collection of number of adverse events.	Day 1 to the end of study Late Follow-Up visit (LFU) (26 ± 2 days)]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Overall Success at End-of-Treatment	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)	End of Treatment Visit (Day 7 - 10 ± 1 day)
Percentage of Subjects With Clinical Cure at End-of-Treatment	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.	End of Treatment Visit (Day 7 - 10 ± 1 day)
Percent of Subjects With Microbiological Eradication at End-of-Treatment	Microbiologic eradication is defined as demonstrating <1000 CFU/mL of the bacterial pathogen found at study entry	End of Treatment Visit (Day 7 - 10 ± 1 day)
Percentage of Subjects With Clinical Cure at Test-of-Cure	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)	Test-of-Cure (Day 17+-2)
Percent of Subjects With Microbiological Eradication at Test-of-Cure	Microbiologic eradication is defined as demonstrating <1000 CFU/mL of the bacterial	Test-of-Cure (Day 17 ± 2 days)
Percentage of Subjects With Clinical Cure at Late Follow-up	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)	Late Follow-up (Day 26 ± 2 days)
Plasma Concentration of FEP-ZID	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).	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

Collaborators and Investigators

• Sponsor: Wockhardt
• Collaborators: Medpace, Inc.
• Investigators: Study Director: Manishkumar D Shah, PhD, Wockhardt

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2022
• Primary Completion (Actual): November 25, 2024
• Study Completion (Actual): November 25, 2024

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Nephritis; Nephritis, Interstitial; Pyelitis; Infections; Communicable Diseases; Urinary Tract Infections; Pyelonephritis; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amides; beta-Lactams; Lactams; Carbapenems; Thienamycins; Meropenem; cefepime-zidebactam
• Other Study ID Numbers: W-5222-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No