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Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
Sponsor: Wockhardt
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.
Official 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
530
Start Date
2022-08-28
Completion Date
2024-11-25
Last Updated
2026-05-22
Healthy Volunteers
No
Interventions
Cefepime-zidebactam (FEP-ZID)
3 g (2 g FEP + 1 g ZID) IV q8h
Meropenem
1 g IV q8h
Locations (48)
S&D Clinical Research, LLC
Fort Myers, Florida, United States
Santos Research Center
Tampa, Florida, United States
MHAT 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
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Deyang People's Hospital
Deyang, China
General hospital of the PLA northern theater command
Liaoyang, China
Fudan University Huashan Hospital
Shanghai, China
Shaoxing 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
Supe Hearth & Diabetes Hospital & Research Centre
Nashik, Maharashtra, India
ACE Hospital and Research Centre
Pune, Maharashtra, India
Accord Hospitals
Pune, Maharashtra, India
Aartham Multi Super Speciality Hospital
Ahmedabad, India
ORIION Citicare Super Speciality Hospital
Aurangabad, India
Klaipedos university hospital
Klaipėda, Lithuania
Republican Vilnius University hospital
Vilnius, Lithuania
Vilnius city clinical hospital
Vilnius, Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
Hospital Angeles Chihuahua
Chihuahua City, Mexico
JM Research Cuernavaca
Cuernavaca, Mexico
Centro 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
Zespol Opieki Zdrowotnej w Boleslawcu
Bolesławiec, Poland
SCM Sp. z o.o.
Krakow, Poland
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi, Oddzial Nefrologii
Lodz, Poland
Wojskowy 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