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

Completed · Phase 3

Conditions studied: Complicated Urinary Tract Infection, Acute Pyelonephritis

In brief

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.

Key facts

Study ID

NCT04979806

Run by

Wockhardt

People needed

530

Starts

2022-08-28

Expected to finish

2024-11-25

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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