Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT05535751
Status:
COMPLETED
Last Update Posted:
2023-12-13
First Post:
2022-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cefepime vs. Carbapenems for Treating AmpC β-lactamase-producing Enterobacteriaceae Bloodstream Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-12', 'studyFirstSubmitDate': '2022-09-06', 'studyFirstSubmitQcDate': '2022-09-06', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital mortality', 'timeFrame': '30 days after infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bacteremia', 'Cefepime', 'carbapenems', 'AmpC β-lactamase', 'enterobacteriaceae bloodstream infections'], 'conditions': ['Bacteremia']}, 'descriptionModule': {'briefSummary': 'Recent international recommendations suggest the use of carbapenem rather than cefepime in this situation, but with a low level of evidence, given the few existing studies. As cefepime is a less broad-spectrum antibiotic than carbapenems, its use would limit the selection of multidrug-resistant bacteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patient (≥18 years of age) managed within a study center for high-grade cephalosporinase-producing bacteremia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Adult patient (≥18 years of age)\n* managed within a study center for high-grade cephalosporinase-producing bacteremia\n* Not objecting to the reuse of their health data for scientific research purposes.\n\nExclusion Criteria:\n\n* Patient who has expressed opposition to the reuse of their data for scientific research purposes.\n* Resistance to Cefepime or carbapenems\n* Multiple bacteremia\n* Treatment with a molecule other than Cefepime or carbapenem.'}, 'identificationModule': {'nctId': 'NCT05535751', 'acronym': 'CARBAPENEM', 'briefTitle': 'Cefepime vs. Carbapenems for Treating AmpC β-lactamase-producing Enterobacteriaceae Bloodstream Infections', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Cefepime vs. Carbapenems for Treating AmpC β-lactamase-producing Enterobacteriaceae Bloodstream Infections', 'orgStudyIdInfo': {'id': '8660'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service des maladies infectieuses et tropicales - CHU de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}