Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-01-09 @ 12:36 PM
Study NCT ID:
NCT03096405
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2017-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact MRSA -PCR on Patient Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-24', 'studyFirstSubmitDate': '2017-03-25', 'studyFirstSubmitQcDate': '2017-03-25', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adaptation duration of antibiotherapy', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Day 30'}, {'measure': 'average duration of hospitalization', 'timeFrame': 'day 30'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['MRSA Bacteremia']}, 'descriptionModule': {'briefSummary': 'Staphylococcus aureus represents one of the most met germs, with Escherichia coli, during bacteremia. Microbiologist distinguish at aureus S. two profiles of resistance in beta-lactamines: S. aureus sensitive to the methicillin ( SASM) and the S. aureus resistant to the methicillin ( SARM).\n\nWith the implementation of the MALDI-TOF, it is now possible to identify the origin responsible of the bacteremia the day of the positivity of the hemoculture ( J0) and to set up a treatment with adapted antibiotic, which, in the case of a sepsis to aureus S., is the vancomycine. Ye it was demonstrated, that the use of the vancomycine on the SASM increased the average duration of stay and a more important rate of relapse.\n\nThe PCR SARM was organized in the GHPSJ in 2014. It allows from the day of the positivity of the hemoculture ( J0), to determine the phenotype of resistance of S. aureus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'every patient hospitalized in St Joseph Hospital with an positive hemoculture to Staphylococcus Aureus Methicillin Sensitive', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hemoculture positive to Staphylococcus Aureus Methicillin Sensitive\n\nExclusion Criteria:\n\n* Positive test to Staphylococcus Aureus Methicillin Sensitive but not hospitalized.'}, 'identificationModule': {'nctId': 'NCT03096405', 'briefTitle': 'Impact MRSA -PCR on Patient Management', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Hôpital Saint-Joseph'}, 'officialTitle': 'Impact MRSA -PCR on Patient Management', 'orgStudyIdInfo': {'id': 'PCR-SARM'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Polymerase Chain Reaction of Methicillin Resistant Staphyloccus Aureus', 'type': 'DIAGNOSTIC_TEST', 'description': 'Polymerase Chain Reaction of Methicillin Resistant Staphyloccus Aureus'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Groupe Hospitalier Paris Saint Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'MIZRAHI Assaf, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Groupe Hospitalier Paris St JOSEPH'}, {'name': 'LEMONNIER Alban, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Groupe Hospitalier Paris St JOSEPH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}