Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2026-01-06 @ 7:53 AM
Study NCT ID:
NCT05350995
Status:
UNKNOWN
Last Update Posted:
2022-08-04
First Post:
2022-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Antibiotherapy Prescribed for Outpatients From Emergency Departments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'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': 'ESTIMATED', 'count': 9600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2022-03-15', 'studyFirstSubmitQcDate': '2022-04-27', 'lastUpdatePostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adequacy to local or national recommendations of antibiotic prescriptions identified on patient discharge prescriptions after a visit in emergency departments.', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Adequacy to local or national recommendations (adequate/not adequate) of prescriptions, assessed by local investigator (infectious disease and/or emergency medicine specialist) at 4 days of collection: 1 day in each season (spring, summer, autumn and winter).'}], 'secondaryOutcomes': [{'measure': 'Adequacy to the local or national recommendations of the antibiotic prescriptions identified on the patient discharge prescriptions by diagnosis.', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Adequacy to local or national recommendations (adequate/not adequate) of the antibiotic prescriptions identified on the patient discharge prescriptions by diagnosis assessed at 4 days of collection: 1 day in each season (spring, summer, autumn and winter).'}, {'measure': 'Antibiotics prescription rate at discharge from emergency department.', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Critical antibiotics prescription rate at discharge from emergency department.', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Critical antibiotics are defined by ANSM guidelines.'}, {'measure': 'Factors associated with inadequacy to the local or national recommendations.', 'timeFrame': 'Through study completion, an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infectious Disease', 'Emergencies']}, 'descriptionModule': {'briefSummary': 'French health insurance data indicate that approximately 15% of ambulatory antibiotic consumption is generated by hospital prescriptions. This extra-hospital consumption represents a greater volume than intra-hospital consumption. To date, hospital indicators of good antibiotic use do not include this outpatient dimension. This study will provide a snapshot of the proportion of ambulatory antibiotics generated by emergencies and analyze compliance with management recommendations.This study will serve as a basis for developing indicators of outpatient antibiotic consumption generated by hospital activity and for identifying specific intervention targets aimed at the misuse situations that have been highlighted.\n\nThis study will be carried out in the form of a repeated survey on a given day (4 days, one across each season), carried out by the local mobile antibiotic therapy team, using a standardized grid. The survey will concern all the medical records of the patients visiting any emergency department on the days of the survey.\n\nThe evaluation of antibiotic therapies prescribed in discharge orders will be carried out in accordance with local management recommendations by the site investigator (infectious disease and/or emergency medicine specialist), who will assess whether the prescription is in accordance with the recommendations or not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All major outpatients visiting an emergency department on one of the survey days.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Visit on emergency department on one of the survey days\n* Age ≥18\n\nExclusion Criteria:\n\n* Patient opposed to the collection of his/her data\n* Patient under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT05350995', 'acronym': 'EVAPAUR', 'briefTitle': 'Evaluation of Antibiotherapy Prescribed for Outpatients From Emergency Departments', 'organization': {'class': 'OTHER', 'fullName': 'Henri Mondor University Hospital'}, 'officialTitle': 'Evaluation of Antibiotherapy Prescribed for Outpatients From Emergency Departments', 'orgStudyIdInfo': {'id': 'U2TI-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Clément Ourghanlian, PharmD', 'role': 'CONTACT'}], 'facility': 'CHU Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'centralContacts': [{'name': 'Clément Ourghanlian, PharmD', 'role': 'CONTACT', 'email': 'clement.ourghanlian@aphp.fr', 'phone': '0145178029', 'phoneExt': '+33'}, {'name': 'Raphael Lepeule, MD', 'role': 'CONTACT', 'email': 'raphael.lepeule@aphp.fr', 'phone': '0145178003', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Clément Ourghanlian, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henri Mondor University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henri Mondor University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Clement OURGHANLIAN', 'investigatorAffiliation': 'Henri Mondor University Hospital'}}}}