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

ClinicalTrials.gov processed this data on June 26, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

RECRUITING (See Contacts and Locations)
Verified June 2024 by Wockhardt, Medpace, Inc.

Sponsor

Wockhardt

Information Provided by (Responsible Party)

Wockhardt

Clinicaltrials.gov Identifier

NCT04979806
Other Study ID Numbers: W-5222-301
First Submitted: July 5, 2021
First Posted: July 28, 2021
Last Update Posted: June 27, 2024
Last Verified: June 2024
History of Changes

Listing a study on this site does not mean it has been evaluated by the U.S. Federal Government. The safety and scientific validity of a study listed on ClinicalTrials.gov is the responsibility of the study sponsor and investigators. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.

ClinicalTrials.gov, a resource provided by the U.S. National Library of Medicine (NLM), is a registry and results information database of clinical research studies sponsored or funded by a broad range of public and private organizations around the world. Not all studies listed on ClinicalTrials.gov are funded by the National Institutes of Health (NIH) or other agencies of the U.S. Federal Government. Not all listed studies are regulated and/or reviewed by the U.S. Food and Drug Administration or other governmental entities.

Information on ClinicalTrials.gov is provided by study sponsors and investigators, and they are responsible for ensuring that the studies follow all applicable laws and regulations. NLM staff do not verify the scientific validity or relevance of the submitted information beyond a limited quality control review for apparent errors, deficiencies, or inconsistencies.

Choosing to participate in a study is an important personal decision. Before you participate in a study, discuss all options with your health care provider and other trusted advisors. For more information about participating in clinical studies, see Learn About Clinical Studies, which includes questions that you might want to ask before deciding to participate in a study.

For more information about using the information on ClinicalTrials.gov, please also see Terms and Conditions.

See also the Web Policies and Notices for the NIH web site.

Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Complicated Urinary Tract Infection
  • Acute Pyelonephritis
  • Drug: Cefepime-zidebactam (FEP-ZID)
  • Drug: Meropenem

Study Design

Study TypeInterventional
Anticipated Enrollment528 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA 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 Start DateAugust 28, 2022
Anticipated Primary Completion DateDecember 2024
Anticipated Study Completion DateDecember 2024

Groups and Cohorts

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

    Outcome Measures

    Primary Outcome Measures

    1. 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)
    2. 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.

    Secondary Outcome Measures

    1. 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)
    2. 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.
    3. 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
    4. 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)
    5. 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
    6. 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)
    7. 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]

    Eligibility Criteria

    Ages Eligible for Study 18 Years and Older (Adult, Older Adult)
    Sexes Eligible for Study All
    Accepts Healthy Volunteers No
    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

    Contacts and Locations

    Sponsors and Collaborators Wockhardt, Medpace, Inc.
    Medpace, Inc.
    Locations
    • Chula Vista | Chula Vista, California, United States, 91911
    • St. Louis | Saint Louis, Missouri, United States, 63110
    • Dobrich | Dobrich, Bulgaria,
    • Pleven | Pleven, Bulgaria,
    • Plovdiv | Plovdiv, Bulgaria, 4003
    • Ruse | Ruse, Bulgaria,
    • Silistra | Silistra, Bulgaria,
    • Sofia | Sofia, Bulgaria, 5800
    • Varna | Varna, Bulgaria,
    • Changsha | Changsha, China, 410005
    • Changsha | Changsha, China, 410011
    • Changsha | Changsha, China, 410018
    • Chengdu | Chengdu, China, 610041
    • Chongqing | Chongqing, China, 400010
    • Liaoyang | Liaoyang, China, 110016
    • Shanghai | Shanghai, China, 200040
    • Kohtla-Jarve | Kohtla-Järve, Estonia,
    • Tallinn | Tallinn, Estonia,
    • Tallinn | Tallin, Estonia,
    • Tartu | Tartu, Estonia,
    • Voru | Võru, Estonia,
    • Ahmedabad | Ahmedabad, Gujarat, India, 380052
    • Sūrat | Sūrat, Gujarat, India, 395002
    • Hisar | Hisar, Haryana, India, 125001
    • Bengaluru | Bengaluru, Karnataka, India, 560001
    • Nagpur | Nagpur, Maharashtra, India, 440003
    • Chandigarh | Chandigarh, Punjab, India, 160012
    • Kolkata | Kolkata, West Bengal, India, 700020
    • Kaunas | Kaunas, Lithuania, 50009
    • Klaipeda | Klaipeda, Lithuania, LT-92288
    • Vilnius | Vilnius, Lithuania, 08661
    • Vilnius | Vilnius, Lithuania, LT-04130
    • Vilnius | Vilnius, Lithuania, LT-10207
    • Chihuahua | Chihuahua, Mexico, 31238
    • Cuernavaca | Cuernavaca, Mexico, 62290
    • Guadalajara | Guadalajara, Mexico, 44280
    • Mérida | Mérida, Mexico, C.P 97000
    • San Luis Potosí | San Luis Potosí, Mexico, 78290
    • Cusco | Cusco, Peru, 08000
    • Iquitos | Iquitos, Peru, 16001
    • Lima | Lima, Peru, 15072
    • Lima | Lima, Peru, 15082
    • Boleslawiec | Bolesławiec, Poland,
    • Krakow | Krakow, Poland, 31-559
    • Lodz | Lodz, Poland, 90-153
    • Ostroleka | Ostroleka, Poland, 07-410

    More Information

    Additional Relevant MeSH Terms

    • Infections
    • Communicable Diseases
    • Urinary Tract Infections
    • Pyelonephritis
    • Disease Attributes
    • Pathologic Processes
    • Urologic Diseases
    • Female Urogenital Diseases
    • Female Urogenital Diseases and Pregnancy Complications
    • Urogenital Diseases
    • Male Urogenital Diseases
    • Nephritis, Interstitial
    • Nephritis
    • Kidney Diseases
    • Pyelitis