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

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified August 2025 by Wockhardt
Sponsor
Wockhardt
Information Provided by (Responsible Party)
Wockhardt
Clinicaltrials.gov Identifier
NCT04979806
Other Study ID Numbers:
W-5222-301
First Submitted
July 4, 2021
First Posted
July 27, 2021
Last Update Posted
September 29, 2025
Last Verified
August 2025

ClinicalTrials.gov processed this data on September 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Complicated Urinary Tract InfectionAcute Pyelonephritis
Drug: Cefepime-zidebactam (FEP-ZID)Drug: Meropenem

Study Design

Study TypeInterventional
Actual Enrollment530 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA 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
Study Start DateAugust 27, 2022
Actual Primary Completion DateNovember 24, 2024
Actual Study Completion DateNovember 24, 2024

Groups and Cohorts

Group/CohortIntervention/Treatment
Cefepime-zidebactam (FEP-ZID)
Drug: Cefepime-zidebactam (FEP-ZID)
3 g (2 g FEP + 1 g ZID) IV q8h
Meropenem
Drug: Meropenem
1 g IV q8h

Outcome Measures

Primary Outcome Measures
  1. 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)
  2. Percentage of subjects with Treatment-Emergent Adverse Events (TEAE)
    Collection of number of adverse events.
Secondary Outcome Measures
  1. 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)
  2. 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.
  3. 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
  4. 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)
  5. Percent of subjects with microbiological eradication at Test-of-Cure
    Microbiologic eradication is defined as demonstrating \<1000 CFU/mL of the bacterial
  6. 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)
  7. Plasma Concentration of FEP-ZID

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

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