Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT05474118
Status:
COMPLETED
Last Update Posted:
2022-07-26
First Post:
2022-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-life Use of Cefazolin for the Treatment of Meticillin-susceptible Staphylococcal Infective Endocarditis: Comparison to a Treatment Cohort With Penicillin M
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D004696', 'term': 'Endocarditis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-21', 'studyFirstSubmitDate': '2022-07-19', 'studyFirstSubmitQcDate': '2022-07-21', 'lastUpdatePostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the efficacy of Cefazolin in the treatment of Staphylococcus meti -S infective endocarditis, with that of Penicillin M, by observing the rate of death, relapse of infective endocarditis and occurence of embolic event.', 'timeFrame': 'Day 10 (End of antibiotic treatment according to national recommendations', 'description': 'The primary outcome is management failure, a composite outcome defined by the existence of at least one of the following:\n\n* Death before the end of treatment\n* Relapse of infective endocarditis, with the same germ, within 3 months of the end of antibiotic therapy\n* Occurrence of embolic event after antibiotic therapy'}], 'secondaryOutcomes': [{'measure': 'Assessment of clinical and biological tolerance', 'timeFrame': '10 days (Occurrence of adverse events during the antibiotic treatment period)', 'description': 'Occurrence of adverse events such as: acute renal failure, coagulation disorder, cytolysis'}, {'measure': 'Description of clinical predictive factors of failure', 'timeFrame': '10 days (during the antibiotic treatment period)', 'description': 'Collection of clinical data in order to identify certain predictive factors of failure using directed acyclic graph.'}, {'measure': 'Description of microbiological predictive factors of failure', 'timeFrame': '10 days (during the antibiotic treatment period)', 'description': 'Collection of microbiological data in order to identify certain predictive factors of failure using directed acyclic graph.'}, {'measure': 'Description of ultrasound predictive factors of failure', 'timeFrame': '10 days (during the antibiotic treatment period)', 'description': 'Collection of ultrasound data in order to identify certain predictive factors of failure using directed acyclic graph.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cefazolin'], 'conditions': ['Infectious Disease', 'Endocarditis']}, 'descriptionModule': {'briefSummary': 'Retrospective, regional, multicenter study (including the Annecy-Genevois Hospital Center, the Chambéry Métropole Savoie Hospital Center, and the Grenoble University Hospital Center), comparing a cohort of patients treated with Cefazolin with a cohort of patients treated with Penicillin M', 'detailedDescription': 'The use of Cefazolin for the treatment of infective endocarditis caused by Staphylococcus meti - S has become commonplace in France following the stockout of injectable Penicillin M, the reference treatment, which occurred during 2016.\n\nThere is currently no clinical data to prejudge the efficacy of Cefazolin in the context of high inoculum, such as in the treatment of infective endocarditis.\n\nOn the other hand, recent data have described a better tolerance profile for Cefazolin than for Penicillin M.\n\nThe objective of this study is to compare the efficacy and safety of Cefazolin with that of Penicillin M in the management of methicillin-susceptible staphylococcal endocarditis, through the analysis of two retrospective cohorts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients included in the study are adults older than 18 years of age, who were treated between 01/01/2014 and 12/31/2018 for definite infective endocarditis according to Duke criteria. The infection must have been documented with Staphylococcus Meti -S, on native valve or device, and treated with Cefazolin or Penicillin M for at least 10 consecutive days.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Definite infective endocarditis according to Duke criteria\n* Documented SAMS or meticillin-sensitive SCN\n* Treated with Cefazolin or Penicillin M for at least 10 consecutive days\n* Treatment initiated between 01/01/2014 and 12/31/2018\n\nExclusion Criteria:\n\n* Patients under 18 years old\n* Patients under 18 years old.'}, 'identificationModule': {'nctId': 'NCT05474118', 'acronym': 'CEFASTA', 'briefTitle': 'Real-life Use of Cefazolin for the Treatment of Meticillin-susceptible Staphylococcal Infective Endocarditis: Comparison to a Treatment Cohort With Penicillin M', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Annecy Genevois'}, 'officialTitle': 'Real-life Use of Cefazolin for the Treatment of Meticillin-susceptible Staphylococcal Infective Endocarditis: Comparison to a Treatment Cohort With Penicillin M', 'orgStudyIdInfo': {'id': '18-45b'}}, 'contactsLocationsModule': {'locations': [{'zip': '74374', 'city': 'Metz-Tessy', 'country': 'France', 'facility': 'Centre Hospitalier Annecy Genevois', 'geoPoint': {'lat': 45.93343, 'lon': 6.10973}}], 'overallOfficials': [{'name': 'Mylène Maillet', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH Annecy Genevois'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Annecy Genevois', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}