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

Acute Pyelonephritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04979806
• Other study ID #: W-5222-301
• Status: Recruiting
• Phase: Phase 3
• Start date: August 28, 2022
• Est. completion date: May 2024

Study information

• Verified date: December 2023
• Source: Wockhardt
• Contact: Medical Monitor, MD
• Phone: 847-894-7392
• Email: clinicaltrials[@]mgp-online.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 528
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pyelonephritis
• Communicable Diseases
• Complicated Urinary Tract Infection
• Infections
• Pyelonephritis
• Urinary Tract Infections

Intervention

Drug:
• Cefepime-zidebactam (FEP-ZID)
3 g (2 g FEP + 1 g ZID) IV q8h
• Meropenem
1 g IV q8h

Locations

Country	Name	City	State
Bulgaria	Dobrich	Dobrich
Bulgaria	Pleven	Pleven
Bulgaria	Plovdiv	Plovdiv
Bulgaria	Ruse	Ruse
Bulgaria	Silistra	Silistra
Bulgaria	Sofia	Sofia
Bulgaria	Varna	Varna
China	Changsha	Changsha
China	Changsha	Changsha
China	Changsha	Changsha
China	Chengdu	Chengdu
China	Chongqing	Chongqing
China	Liaoyang	Liaoyang
China	Shanghai	Shanghai
Estonia	Kohtla-Jarve	Kohtla-Järve
Estonia	Tallinn	Tallin
Estonia	Tallinn	Tallinn
Estonia	Tartu	Tartu
Estonia	Voru	Võru
India	Ahmedabad	Ahmedabad	Gujarat
India	Bengaluru	Bengaluru	Karnataka
India	Chandigarh	Chandigarh	Punjab
India	Hisar	Hisar	Haryana
India	Kolkata	Kolkata	West Bengal
India	Nagpur	Nagpur	Maharashtra
India	Surat	Surat	Gujarat
Lithuania	Kaunas	Kaunas
Lithuania	Klaipeda	Klaipeda
Lithuania	Vilnius	Vilnius
Lithuania	Vilnius	Vilnius
Lithuania	Vilnius	Vilnius
Mexico	Chihuahua	Chihuahua
Mexico	Cuernavaca	Cuernavaca
Mexico	Guadalajara	Guadalajara
Mexico	Mérida	Mérida
Mexico	San Luis Potosí	San Luis Potosí
Peru	Cusco	Cusco
Peru	Iquitos	Iquitos
Peru	Lima	Lima
Peru	Lima	Lima
Poland	Boleslawiec	Boleslawiec
Poland	Krakow	Krakow
Poland	Lodz	Lodz
Poland	Ostroleka	Ostroleka
United States	Chula Vista	Chula Vista	California
United States	St. Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Wockhardt	Medpace, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  China,  Estonia,  India,  Lithuania,  Mexico,  Peru,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Test Of Cure Visit (Day 17 ± 2 days)
Primary	Percentage of subjects with Treatment-Emergent Adverse Events (TEAE)	Collection of number of adverse events.	Day 1 to the end of study Late Follow-Up visit (LFU) (26 ± 2 days)]
Secondary	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)	End of Treatment Visit (Day 7 - 10 ± 1 day)
Secondary	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.	End of Treatment Visit (Day 7 - 10 ± 1 day)
Secondary	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	End of Treatment Visit (Day 7 - 10 ± 1 day)
Secondary	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)	End of Treatment Visit (Day 17 ± 2 days)
Secondary	Percent of subjects with microbiological eradication at Test-of-Cure	Microbiologic eradication is defined as demonstrating <1000 CFU/mL of the bacterial	End of Treatment Visit (Day 17 ± 2 days)
Secondary	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)	End of Treatment Visit (Day 26 ± 2 days)
Secondary	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