Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
NCT ID: NCT04979806
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
530 participants
INTERVENTIONAL
2022-08-28
2024-11-25
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cefepime-zidebactam (FEP-ZID)
Cefepime-zidebactam (FEP-ZID)
3 g (2 g FEP + 1 g ZID) IV q8h
Meropenem
Meropenem
1 g IV q8h
Interventions
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Cefepime-zidebactam (FEP-ZID)
3 g (2 g FEP + 1 g ZID) IV q8h
Meropenem
1 g IV q8h
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Medpace, Inc.
INDUSTRY
Wockhardt
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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W-5222-301
Identifier Type: -
Identifier Source: org_study_id
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