Clinical trial NCT04979806: Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Complicated Urinary Tract Infection
Acute Pyelonephritis
Lead sponsor: Wockhardt
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
First posted: 2021-07-28
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Male or female ≥ 18 years of age
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:

1. Known or suspected disease that may confound the assessment of efficacy.
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

Primary outcomes:
measure: Percentage of subjects with overall success at Test-of-Cure
timeFrame: Test Of Cure Visit (Day 17 ± 2 days)
measure: Percentage of subjects with Treatment-Emergent Adverse Events (TEAE)
timeFrame: Day 1 to the end of study Late Follow-Up visit (LFU) (26 ± 2 days)]
Secondary outcomes:
measure: Percentage of subjects with overall success at End-of-Treatment
timeFrame: End of Treatment Visit (Day 7 - 10 ± 1 day)
measure: Percentage of subjects with clinical cure at End-of-Treatment
timeFrame: End of Treatment Visit (Day 7 - 10 ± 1 day)
measure: Percent of subjects with microbiological eradication at End-of-Treatment
timeFrame: End of Treatment Visit (Day 7 - 10 ± 1 day)
measure: Percentage of subjects with clinical cure at Test-of-Cure
timeFrame: End of Treatment Visit (Day 17 ± 2 days)
measure: Percent of subjects with microbiological eradication at Test-of-Cure
timeFrame: End of Treatment Visit (Day 17 ± 2 days)
measure: Percentage of subjects with clinical cure at Late Follow-up
timeFrame: End of Treatment Visit (Day 26 ± 2 days)
measure: Plasma Concentration of FEP-ZID
timeFrame: 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
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: S&D Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: Santos Research Center
state: Florida
city: Dobrich
country: Bulgaria
facility: MHAT Dobrich AD
city: Pleven
country: Bulgaria
facility: UMHAT Dr. Georgi Stranski
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Plovdiv AD, Plovdiv
city: Ruse
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - KANEV
city: Silistra
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment (MHAT)- Silistra
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Pirogov
city: Sofia
country: Bulgaria
facility: UMHAT Aleksandrovska Sofia - Clinic of Urology, Clinic of Anaesthesiology and Intensive Care, Clinic of Clinical Hematology
city: Varna
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment (MHAT) Sveta Anna - Varna
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
city: Deyang City
country: China
facility: Deyang People's Hospital
city: Liaoyang
country: China
facility: General hospital of the PLA northern theater command
city: Shanghai
country: China
facility: Fudan University Huashan Hospital
city: Shaoxing
country: China
facility: Shaoxing People's Hospital
city: Kohtla-Järve
country: Estonia
facility: Ida-Viru Central Hospital
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Tallin
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Võru
country: Estonia
facility: South-Estonian Hospital Ltd.
city: Chhatrapati Sambhajinagar
country: India
facility: Super Speciality Hospital Government Medical College and Hospital
state: Maharashtra
city: Erandwada, Pune
country: India
facility: ACE Hospital and Research Centre
state: Maharashtra
city: Pimpri-Chinchwad, Pune
country: India
facility: Accord Hospitals
state: Maharashtra
city: Ahmedabad
country: India
facility: Aartham Multi Super Speciality Hospital
city: Ashok Stambh, Nasik
country: India
facility: Supe Hearth & Diabetes Hospital & Research Centre
city: Chhatrapati Sambhajinagar
country: India
facility: ORIION Citicare Super Speciality Hospital
city: Klaipeda
country: Lithuania
facility: Klaipedos university hospital
city: Vilnius
country: Lithuania
facility: Republican Vilnius University hospital
city: Vilnius
country: Lithuania
facility: Vilnius city clinical hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
city: Chihuahua
country: Mexico
facility: Hospital Angeles Chihuahua
city: Cuernavaca
country: Mexico
facility: JM Research Cuernavaca
city: Merida, Yucatan
country: Mexico
facility: Unidad de Atención Médica e Investigación en Salud (Unamis)
city: Oaxaca
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca (CICLO)
city: Queretaro Qro
country: Mexico
facility: Pharmacology & Clinical Research
city: Veracruz
country: Mexico
facility: Arke SMO S.A. de C.V.
city: Bolesławiec
country: Poland
facility: Zespol Opieki Zdrowotnej w Boleslawcu
city: Krakow
country: Poland
facility: SCM Sp. z o.o.
city: Lodz
country: Poland
facility: Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi, Oddzial Nefrologii
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Chorob Wewnetrznych, Nefrologii i Dializoterapii
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
city: Nitra
country: Slovakia
facility: Fakultna nemocnica Nitra
city: Poprad
country: Slovakia
facility: Nemocnica Poprad, a.s. Urologicke oddeleni
city: Zilina
country: Slovakia
facility: Fakultna nemocnica s poliklinikou Zilina
Study officials:
References: