Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
- Conditions
- Complicated Urinary Tract InfectionAcute Pyelonephritis
- Interventions
- Drug: Cefepime-zidebactam (FEP-ZID)
- Registration Number
- NCT04979806
- Lead Sponsor
- Wockhardt
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 530
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cefepime-zidebactam (FEP-ZID) Cefepime-zidebactam (FEP-ZID) - Meropenem Meropenem -
- Primary Outcome Measures
Name Time Method Percentage of subjects with Treatment-Emergent Adverse Events (TEAE) Day 1 to the end of study Late Follow-Up visit (LFU) (26 ± 2 days)] Collection of number of adverse events.
Percentage of subjects with overall success at Test-of-Cure Test Of Cure Visit (Day 17 ± 2 days) 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)
- Secondary Outcome Measures
Name Time Method Percent of subjects with microbiological eradication at Test-of-Cure End of Treatment Visit (Day 17 ± 2 days) Microbiologic eradication is defined as demonstrating \<1000 CFU/mL of the bacterial
Plasma Concentration of FEP-ZID On Days 1 and 3 of dosing prior to infusion, within 15 minutes after the end of infusion, and at 3 timepoints up to 7 hours hours post infusion Percentage of subjects with overall success at End-of-Treatment End of Treatment Visit (Day 7 - 10 ± 1 day) 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)
Percentage of subjects with clinical cure at End-of-Treatment End of Treatment Visit (Day 7 - 10 ± 1 day) 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.
Percent of subjects with microbiological eradication at End-of-Treatment End of Treatment Visit (Day 7 - 10 ± 1 day) Microbiologic eradication is defined as demonstrating \<1000 CFU/mL of the bacterial pathogen found at study entry
Percentage of subjects with clinical cure at Test-of-Cure End of Treatment Visit (Day 17 ± 2 days) 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)
Percentage of subjects with clinical cure at Late Follow-up End of Treatment Visit (Day 26 ± 2 days) 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)
Trial Locations
- Locations (48)
Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Pirogov
🇧🇬Sofia, Bulgaria
Centro de Investigacion Clinica de Oaxaca (CICLO)
🇲🇽Oaxaca, Mexico
Pharmacology & Clinical Research
🇲🇽Queretaro Qro, Mexico
Arke SMO S.A. de C.V.
🇲🇽Veracruz, Mexico
Zespol Opieki Zdrowotnej w Boleslawcu
🇵🇱Bolesławiec, Poland
SCM Sp. z o.o.
🇵🇱Krakow, Poland
Fakultna nemocnica Nitra
🇸🇰Nitra, Slovakia
Nemocnica Poprad, a.s. Urologicke oddeleni
🇸🇰Poprad, Slovakia
Fakultna nemocnica s poliklinikou Zilina
🇸🇰Zilina, Slovakia
Multiprofile Hospital for Active Treatment - KANEV
🇧🇬Ruse, Bulgaria
Unidad de Atención Médica e Investigación en Salud (Unamis)
🇲🇽Merida, Yucatan, Mexico
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 (MHAT)- Silistra
🇧🇬Silistra, Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
🇧🇬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 City, 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
West Tallinn Central Hospital
🇪🇪Tallinn, Estonia
North Estonia Medical Centre Foundation
🇪🇪Tallin, Estonia
Tartu University Hospital
🇪🇪Tartu, Estonia
South-Estonian Hospital Ltd.
🇪🇪Võru, Estonia
Super Speciality Hospital Government Medical College and Hospital
🇮🇳Chhatrapati Sambhajinagar, Maharashtra, India
ACE Hospital and Research Centre
🇮🇳Erandwada, Pune, Maharashtra, India
Accord Hospitals
🇮🇳Pimpri-Chinchwad, Pune, Maharashtra, India
Aartham Multi Super Speciality Hospital
🇮🇳Ahmedabad, India
Supe Hearth & Diabetes Hospital & Research Centre
🇮🇳Ashok Stambh, Nasik, India
ORIION Citicare Super Speciality Hospital
🇮🇳Chhatrapati Sambhajinagar, India
Klaipedos university hospital
🇱🇹Klaipeda, Lithuania
Republican Vilnius University hospital
🇱🇹Vilnius, Lithuania
Vilnius city clinical hospital
🇱🇹Vilnius, Lithuania
Vilnius University Hospital Santaros Klinikos
🇱🇹Vilnius, Lithuania
Hospital Angeles Chihuahua
🇲🇽Chihuahua, Mexico
JM Research Cuernavaca
🇲🇽Cuernavaca, Mexico
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
🇵🇱Warszawa, Poland
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
🇸🇰Banska Bystrica, Slovakia