Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2026-01-01 @ 2:37 AM
Study NCT ID:
NCT04979806
Status:
COMPLETED
Last Update Posted:
2025-09-30
First Post:
2021-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belarus', 'Peru']}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624485', 'term': 'cefepime-zidebactam'}, {'id': 'D000077731', 'term': 'Meropenem'}], 'ancestors': [{'id': 'D013845', 'term': 'Thienamycins'}, {'id': 'D015780', 'term': 'Carbapenems'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 530}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2021-07-05', 'studyFirstSubmitQcDate': '2021-07-16', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects with overall success at Test-of-Cure', 'timeFrame': 'Test Of Cure Visit (Day 17 ± 2 days)', '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)'}, {'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)]', 'description': 'Collection of number of adverse events.'}], 'secondaryOutcomes': [{'measure': 'Percentage of subjects with overall success at End-of-Treatment', 'timeFrame': 'End of Treatment Visit (Day 7 - 10 ± 1 day)', '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)'}, {'measure': 'Percentage of subjects with clinical cure at End-of-Treatment', 'timeFrame': 'End of Treatment Visit (Day 7 - 10 ± 1 day)', '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.'}, {'measure': 'Percent of subjects with microbiological eradication at End-of-Treatment', 'timeFrame': 'End of Treatment Visit (Day 7 - 10 ± 1 day)', 'description': 'Microbiologic eradication is defined as demonstrating \\<1000 CFU/mL of the bacterial pathogen found at study entry'}, {'measure': 'Percentage of subjects with clinical cure at Test-of-Cure', 'timeFrame': 'End of Treatment Visit (Day 17 ± 2 days)', '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)'}, {'measure': 'Percent of subjects with microbiological eradication at Test-of-Cure', 'timeFrame': 'End of Treatment Visit (Day 17 ± 2 days)', 'description': 'Microbiologic eradication is defined as demonstrating \\<1000 CFU/mL of the bacterial'}, {'measure': 'Percentage of subjects with clinical cure at Late Follow-up', 'timeFrame': 'End of Treatment Visit (Day 26 ± 2 days)', '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)'}, {'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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complicated Urinary Tract Infection', 'Acute Pyelonephritis']}, 'descriptionModule': {'briefSummary': '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.\n\nApproximately 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female ≥ 18 years of age\n2. Provide a signed written informed consent prior to any study-specific procedures\n3. Meet the clinical criteria for either cUTI or AP\n4. Requires hospitalization to manage the cUTI or AP\n5. Agrees to use effective methods of contraception\n\nExclusion Criteria:\n\n1. Known or suspected disease that may confound the assessment of efficacy.\n2. 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.\n3. Rapidly progressive illness such that the subject is unlikely to survive the study period.\n4. Pregnant or breastfeeding women\n5. History of a seizure disorder requiring current treatment\n6. Creatinine clearance \\< 15 mL/min or on renal dialysis\n7. Neutropenia or elevated liver enzymes\n8. Hypersensitivity to beta-lactam antibiotics\n9. Unlikely to comply with the protocol or the Investigator considers that study participation may not be optimal for the subject'}, 'identificationModule': {'nctId': 'NCT04979806', 'briefTitle': 'Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wockhardt'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'W-5222-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cefepime-zidebactam (FEP-ZID)', 'interventionNames': ['Drug: Cefepime-zidebactam (FEP-ZID)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Meropenem', 'interventionNames': ['Drug: Meropenem']}], 'interventions': [{'name': 'Cefepime-zidebactam (FEP-ZID)', 'type': 'DRUG', 'description': '3 g (2 g FEP + 1 g ZID) IV q8h', 'armGroupLabels': ['Cefepime-zidebactam (FEP-ZID)']}, {'name': 'Meropenem', 'type': 'DRUG', 'description': '1 g IV q8h', 'armGroupLabels': ['Meropenem']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33919', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'S&D Clinical Research, LLC', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33615', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Santos Research Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Dobrich', 'country': 'Bulgaria', 'facility': 'MHAT Dobrich AD', 'geoPoint': {'lat': 43.56491, 'lon': 27.83138}}, {'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'UMHAT Dr. Georgi Stranski', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Multiprofile Hospital for Active Treatment - 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