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

PHASE3CompletedINTERVENTIONAL
Enrollment

530

Participants

Timeline

Start Date

August 28, 2022

Primary Completion Date

November 25, 2024

Study Completion Date

November 25, 2024

Conditions
Complicated Urinary Tract InfectionAcute Pyelonephritis
Interventions
DRUG

Cefepime-zidebactam (FEP-ZID)

3 g (2 g FEP + 1 g ZID) IV q8h

DRUG

Meropenem

1 g IV q8h

Trial Locations (48)

31238

Hospital Angeles Chihuahua, Chihuahua City

33615

Santos Research Center, Tampa

33919

S&D Clinical Research, LLC, Fort Myers

62290

JM Research Cuernavaca, Cuernavaca

200040

Fudan University Huashan Hospital, Shanghai

380006

Aartham Multi Super Speciality Hospital, Ahmedabad

400010

The Second Affiliated Hospital of Chongqing Medical University, Chongqing

411004

ACE Hospital and Research Centre, Pune

412105

Accord Hospitals, Pune

422002

Supe Hearth & Diabetes Hospital & Research Centre, Nashik

431004

Super Speciality Hospital Government Medical College and Hospital, Aurangabad

431005

ORIION Citicare Super Speciality Hospital, Aurangabad

610041

West China Hospital, Sichuan University, Chengdu

Unknown

MHAT Dobrich AD, Dobrich

UMHAT Dr. Georgi Stranski, Pleven

Multiprofile Hospital for Active Treatment - Plovdiv AD, Plovdiv, Plovdiv

Multiprofile Hospital for Active Treatment - KANEV, Rousse

Multiprofile Hospital for Active Treatment (MHAT)- Silistra, Silistra

Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD, Sofia

Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Pirogov, Sofia

UMHAT Aleksandrovska Sofia - Clinic of Urology, Clinic of Anaesthesiology and Intensive Care, Clinic of Clinical Hematology, Sofia

Multiprofile Hospital for Active Treatment (MHAT) Sveta Anna - Varna, Varna

Hunan Provincial People's Hospital, Changsha

The Second Xiangya Hospital of Central South University, Changsha

Deyang People's Hospital, Deyang

General hospital of the PLA northern theater command, Liaoyang

Shaoxing People's Hospital, Shaoxing

Ida-Viru Central Hospital, Kohtla-Järve

North Estonia Medical Centre Foundation, Tallinn

West Tallinn Central Hospital, Tallinn

Tartu University Hospital, Tartu

South-Estonian Hospital Ltd., Võru

Republican Vilnius University hospital, Vilnius

Vilnius city clinical hospital, Vilnius

Vilnius University Hospital Santaros Klinikos, Vilnius

Centro de Investigacion Clinica de Oaxaca (CICLO), Oaxaca City

Pharmacology & Clinical Research, Querétaro

Arke SMO S.A. de C.V., Veracruz

Zespol Opieki Zdrowotnej w Boleslawcu, Bolesławiec

Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Chorob Wewnetrznych, Nefrologii i Dializoterapii, Warsaw

Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica, Banská Bystrica

Fakultna nemocnica Nitra, Nitra

Nemocnica Poprad, a.s. Urologicke oddeleni, Poprad

Fakultna nemocnica s poliklinikou Zilina, Žilina

LT-92288

Klaipedos university hospital, Klaipėda

C.P 97000

Unidad de Atención Médica e Investigación en Salud (Unamis), Yucatán

31-559

SCM Sp. z o.o., Krakow

90-153

Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi, Oddzial Nefrologii, Lodz

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Medpace, Inc.

INDUSTRY

lead

Wockhardt

INDUSTRY