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

Primary Purpose

Complicated Urinary Tract Infection, Acute Pyelonephritis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cefepime-zidebactam (FEP-ZID)
Meropenem
Sponsored by
Wockhardt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complicated Urinary Tract Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chula Vista
  • St. Louis
  • DobrichRecruiting
  • PlevenRecruiting
  • PlovdivRecruiting
  • RuseRecruiting
  • SilistraRecruiting
  • SofiaRecruiting
  • VarnaRecruiting
  • Changsha
  • Changsha
  • Changsha
  • Chengdu
  • Chongqing
  • Liaoyang
  • Shanghai
  • Kohtla-JarveRecruiting
  • TallinnRecruiting
  • TallinnRecruiting
  • TartuRecruiting
  • VoruRecruiting
  • Ahmedabad
  • Sūrat
  • Hisar
  • Bengaluru
  • Nagpur
  • Chandigarh
  • Kolkata
  • KaunasRecruiting
  • KlaipedaRecruiting
  • VilniusRecruiting
  • VilniusRecruiting
  • VilniusRecruiting
  • Chihuahua
  • Cuernavaca
  • Guadalajara
  • Mérida
  • San Luis Potosí
  • Cusco
  • Iquitos
  • Lima
  • Lima
  • BoleslawiecRecruiting
  • KrakowRecruiting
  • LodzRecruiting
  • Ostroleka

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cefepime-zidebactam (FEP-ZID)

Meropenem

Arm Description

Outcomes

Primary Outcome Measures

Percentage of subjects with overall success at Test-of-Cure
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)
Percentage of subjects with Treatment-Emergent Adverse Events (TEAE)
Collection of number of adverse events.

Secondary Outcome Measures

Percentage of subjects with overall success at End-of-Treatment
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
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
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
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)
Percent of subjects with microbiological eradication at Test-of-Cure
Microbiologic eradication is defined as demonstrating <1000 CFU/mL of the bacterial
Percentage of subjects with clinical cure at Late Follow-up
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)
Plasma Concentration of FEP-ZID

Full Information

First Posted
July 5, 2021
Last Updated
May 16, 2023
Sponsor
Wockhardt
Collaborators
Medpace, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04979806
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wockhardt
Collaborators
Medpace, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complicated Urinary Tract Infection, Acute Pyelonephritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
528 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cefepime-zidebactam (FEP-ZID)
Arm Type
Experimental
Arm Title
Meropenem
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Cefepime-zidebactam (FEP-ZID)
Intervention Description
3 g (2 g FEP + 1 g ZID) IV q8h
Intervention Type
Drug
Intervention Name(s)
Meropenem
Intervention Description
1 g IV q8h
Primary Outcome Measure Information:
Title
Percentage of subjects with overall success at Test-of-Cure
Description
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)
Time Frame
Test Of Cure Visit (Day 17 ± 2 days)
Title
Percentage of subjects with Treatment-Emergent Adverse Events (TEAE)
Description
Collection of number of adverse events.
Time Frame
Day 1 to the end of study Late Follow-Up visit (LFU) (26 ± 2 days)]
Secondary Outcome Measure Information:
Title
Percentage of subjects with overall success at End-of-Treatment
Description
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)
Time Frame
End of Treatment Visit (Day 7 - 10 ± 1 day)
Title
Percentage of subjects with clinical cure at End-of-Treatment
Description
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.
Time Frame
End of Treatment Visit (Day 7 - 10 ± 1 day)
Title
Percent of subjects with microbiological eradication at End-of-Treatment
Description
Microbiologic eradication is defined as demonstrating <1000 CFU/mL of the bacterial pathogen found at study entry
Time Frame
End of Treatment Visit (Day 7 - 10 ± 1 day)
Title
Percentage of subjects with clinical cure at Test-of-Cure
Description
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)
Time Frame
End of Treatment Visit (Day 17 ± 2 days)
Title
Percent of subjects with microbiological eradication at Test-of-Cure
Description
Microbiologic eradication is defined as demonstrating <1000 CFU/mL of the bacterial
Time Frame
End of Treatment Visit (Day 17 ± 2 days)
Title
Percentage of subjects with clinical cure at Late Follow-up
Description
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)
Time Frame
End of Treatment Visit (Day 26 ± 2 days)
Title
Plasma Concentration of FEP-ZID
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical Monitor, MD
Phone
847-894-7392
Email
clinicaltrials@mgp-online.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manishkumar D Shah, PhD
Organizational Affiliation
Wockhardt
Official's Role
Study Director
Facility Information:
Facility Name
Chula Vista
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Dobrich
City
Dobrich
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Pleven
City
Pleven
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Plovdiv
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Ruse
City
Ruse
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Silistra
City
Silistra
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Sofia
City
Sofia
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Varna
City
Varna
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Changsha
City
Changsha
ZIP/Postal Code
410005
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Changsha
City
Changsha
ZIP/Postal Code
410011
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Changsha
City
Changsha
ZIP/Postal Code
410018
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Chengdu
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Chongqing
City
Chongqing
ZIP/Postal Code
400010
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Liaoyang
City
Liaoyang
ZIP/Postal Code
110016
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Shanghai
City
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Kohtla-Jarve
City
Kohtla-Järve
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Tallinn
City
Tallinn
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Tallinn
City
Tallin
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Tartu
City
Tartu
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Voru
City
Võru
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Ahmedabad
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380052
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Sūrat
City
Sūrat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Hisar
City
Hisar
State/Province
Haryana
ZIP/Postal Code
125001
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Bengaluru
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
560001
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Nagpur
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440003
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Chandigarh
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160012
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Kolkata
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700020
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Kaunas
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Klaipeda
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Vilnius
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Vilnius
City
Vilnius
ZIP/Postal Code
LT-04130
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Vilnius
City
Vilnius
ZIP/Postal Code
LT-10207
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Chihuahua
City
Chihuahua
ZIP/Postal Code
31238
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Cuernavaca
City
Cuernavaca
ZIP/Postal Code
62290
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Guadalajara
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Mérida
City
Mérida
ZIP/Postal Code
C.P 97000
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
San Luis Potosí
City
San Luis Potosí
ZIP/Postal Code
78290
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Cusco
City
Cusco
ZIP/Postal Code
08000
Country
Peru
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Iquitos
City
Iquitos
ZIP/Postal Code
16001
Country
Peru
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Lima
City
Lima
ZIP/Postal Code
15072
Country
Peru
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Lima
City
Lima
ZIP/Postal Code
15082
Country
Peru
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Boleslawiec
City
Bolesławiec
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Krakow
City
Krakow
ZIP/Postal Code
31-559
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Lodz
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator
Facility Name
Ostroleka
City
Ostroleka
ZIP/Postal Code
07-410
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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