Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-01-01 @ 4:21 PM
Study NCT ID:
NCT07226557
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-10
First Post:
2025-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cefiderocol vs Best Available Therapy for Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex Infections: A Target Trial Emulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-09-02', 'size': 181724, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-11-06T14:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-07', 'studyFirstSubmitDate': '2025-11-05', 'studyFirstSubmitQcDate': '2025-11-07', 'lastUpdatePostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'During inpatient admission', 'description': 'In hospital mortality or discharge to hospice during the hospital stay'}], 'secondaryOutcomes': [{'measure': 'Length of Stay', 'timeFrame': 'Inpatient admission', 'description': 'Duration of hospitalization among surviving patients'}, {'measure': 'Recurrent CRAB Infection', 'timeFrame': 'Within 30 days post discharge', 'description': 'clinical culture positive for carbapenem-resistant A. baumannii (CRAB) infection within the same encounter downstream of the index episode and within 30 days.'}, {'measure': 'Development of antibiotic resistance to initial antibiotic treatment', 'timeFrame': 'Subsequent admissions', 'description': 'Development of antibiotic resistance on a subsequent positive clinical culture to an antibiotic administered during prior infectious episode'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carbapenem-resistant Acinetobacter baumannii', 'Cefiderocol', 'Target trial emulation'], 'conditions': ['Carbapenem Resistant Bacterial Infection', 'Acinetobacter Baumannii Infection', 'Antimicrobial Drug Resistance']}, 'descriptionModule': {'briefSummary': 'This study aims to compare 28-day mortality among patients with carbapenem resistant A. baumannii infections in two hypothetical target trials where patients receive 7 days of a cefiderocol-based treatment strategy or 7 days of a best available therapy treatment strategy.', 'detailedDescription': 'please see uploaded study protocol'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized adult patients with a clinical culture positive for carbapenem resistant A. baumannii and received an antibiotic with possible in vitro activity against carbapenem resistant A. baumannii in the time frame of interest (i.e., days before culture collection until 2 days after first available antibiotic susceptibility test result was made available) and admitted to US hospitals reporting to the PINC-AI healthcare database between 2018-2024 will be eligible for inclusion in the hypothetical target trials.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized adults (≥ 18 years of age)\n* Carbapenem resistant A. baumannii-calcoaceticus complex clinical culture\n* Antimicrobial agent with possible in vitro activity against carbapenem resistant A. baumannii-calcoaceticus complex initiated in the time frame of 2 days before culture collection until 2 days following first available antibiotic susceptibility test result being made available\n\nExclusion Criteria:\n\n* Patients with no antibiotic susceptibility testing\n* Patients with only A. baumannii infection diagnosed by rapid diagnostic tests (i.e., multiplex polymerase chain reaction)\n* Initiation of antimicrobial agent outside of selected time frame (i.e., 2 days before culture collection until 2 days after first available antibiotic susceptibility test result was made available)'}, 'identificationModule': {'nctId': 'NCT07226557', 'briefTitle': 'Cefiderocol vs Best Available Therapy for Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex Infections: A Target Trial Emulation', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Cefiderocol vs Best Available Therapy for Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex Infections: A Target Trial Emulation', 'orgStudyIdInfo': {'id': 'BD070725'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Reciept of cefiderocol', 'description': 'Inpatients with carbapenem-resistant Acinetobacter baumannii infection that receive empiric and/or targeted therapy including cefiderocol.'}, {'label': 'Reciept of best available therapy (BAT)', 'description': 'Inpatients with carbapenem-resistant Acinetobacter baumannii infection that receive empiric and/or targeted therapy with activity against the infection but does not include cefiderocol'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Sameer Kadri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institutes of Health CC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Aggregate data, analytic methods, and data dictionary will be shared upon request to the primary contact.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institutes of Health Clinical Center (CC)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}