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

NCT04979806 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: W-5222-301
• Study Type: interventional
• Target: 530
• Locations: 9 countries
• Sites: 48

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Percentage of subjects with overall success at End-of-Treatment

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

• Percentage of subjects with clinical cure at End-of-Treatment

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

• Percent of subjects with microbiological eradication at End-of-Treatment

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

• Percentage of subjects with clinical cure at Test-of-Cure

  End of Treatment Visit (Day 17 ± 2 days)

• Percent of subjects with microbiological eradication at Test-of-Cure

  End of Treatment Visit (Day 17 ± 2 days)

Study Arms (2)

Cefepime-zidebactam (FEP-ZID)

EXPERIMENTAL

Drug: Cefepime-zidebactam (FEP-ZID)

Meropenem

ACTIVE COMPARATOR

Drug: Meropenem

Interventions

Cefepime-zidebactam (FEP-ZID) DRUG

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

Cefepime-zidebactam (FEP-ZID)

Meropenem DRUG

1 g IV q8h

Meropenem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wockhardt: lead
• Medpace, Inc.: collaborator

Study Sites (48)

S&D Clinical Research, LLC

Fort Myers, Florida, 33919, United States

Location

Santos Research Center

Tampa, Florida, 33615, United States

Location

MHAT Dobrich AD

Dobrich, Bulgaria

Location

UMHAT Dr. Georgi Stranski

Pleven, Bulgaria

Location

Multiprofile Hospital for Active Treatment - Plovdiv AD, Plovdiv

Plovdiv, Bulgaria

Location

Multiprofile Hospital for Active Treatment - KANEV

Rousse, Bulgaria

Location

Multiprofile Hospital for Active Treatment (MHAT)- Silistra

Silistra, Bulgaria

Location

Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD

Sofia, Bulgaria

Location

Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Pirogov

Sofia, Bulgaria

Location

UMHAT Aleksandrovska Sofia - Clinic of Urology, Clinic of Anaesthesiology and Intensive Care, Clinic of Clinical Hematology

Sofia, Bulgaria

Location

Multiprofile Hospital for Active Treatment (MHAT) Sveta Anna - Varna

Varna, Bulgaria

Location

Hunan Provincial People's Hospital

Changsha, China

Location

The Second Xiangya Hospital of Central South University

Changsha, China

Location

West China Hospital, Sichuan University

Chengdu, 610041, China

Location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, 400010, China

Location

Deyang People's Hospital

Deyang, China

Location

General hospital of the PLA northern theater command

Liaoyang, China

Location

Fudan University Huashan Hospital

Shanghai, 200040, China

Location

Shaoxing People's Hospital

Shaoxing, China

Location

Ida-Viru Central Hospital

Kohtla-Järve, Estonia

Location

North Estonia Medical Centre Foundation

Tallinn, Estonia

Location

West Tallinn Central Hospital

Tallinn, Estonia

Location

Tartu University Hospital

Tartu, Estonia

Location

South-Estonian Hospital Ltd.

Võru, Estonia

Location

Super Speciality Hospital Government Medical College and Hospital

Aurangabad, Maharashtra, 431004, India

Location

Supe Hearth & Diabetes Hospital & Research Centre

Nashik, Maharashtra, 422002, India

Location

ACE Hospital and Research Centre

Pune, Maharashtra, 411004, India

Location

Accord Hospitals

Pune, Maharashtra, 412105, India

Location

Aartham Multi Super Speciality Hospital

Ahmedabad, 380006, India

Location

ORIION Citicare Super Speciality Hospital

Aurangabad, 431005, India

Location

Klaipedos university hospital

Klaipėda, LT-92288, Lithuania

Location

Republican Vilnius University hospital

Vilnius, Lithuania

Location

Vilnius city clinical hospital

Vilnius, Lithuania

Location

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Location

Hospital Angeles Chihuahua

Chihuahua City, 31238, Mexico

Location

JM Research Cuernavaca

Cuernavaca, 62290, Mexico

Location

Centro de Investigacion Clinica de Oaxaca (CICLO)

Oaxaca City, Mexico

Location

Pharmacology & Clinical Research

Querétaro, Mexico

Location

Arke SMO S.A. de C.V.

Veracruz, Mexico

Location

Unidad de Atención Médica e Investigación en Salud (Unamis)

Yucatán, C.P 97000, Mexico

Location

Zespol Opieki Zdrowotnej w Boleslawcu

Bolesławiec, Poland

Location

SCM Sp. z o.o.

Krakow, 31-559, Poland

Location

Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi, Oddzial Nefrologii

Lodz, 90-153, Poland

Location

Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Chorob Wewnetrznych, Nefrologii i Dializoterapii

Warsaw, Poland

Location

Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica

Banská Bystrica, Slovakia

Location

Fakultna nemocnica Nitra

Nitra, Slovakia

Location

Nemocnica Poprad, a.s. Urologicke oddeleni

Poprad, Slovakia

Location

Fakultna nemocnica s poliklinikou Zilina

Žilina, Slovakia

Location

MeSH Terms

Interventions

cefepime-zidebactam; Meropenem

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 28, 2021
• Study Start: August 28, 2022
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

IN (6); BU (9); ME (6); US (2); ES (5); CN (8); PL (4); SL (4); LI (4)