Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-02-19 @ 5:20 AM
Study NCT ID:
NCT03928951
Status:
COMPLETED
Last Update Posted:
2019-11-29
First Post:
2019-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
General Practitioner Reassessment of Urinary Infection Antibiotherapy Prescribed by Emergency Departments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-27', 'studyFirstSubmitDate': '2019-04-24', 'studyFirstSubmitQcDate': '2019-04-24', 'lastUpdatePostDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of antibiotherapies modified by general practitioners', 'timeFrame': '6 months', 'description': 'Number of antibiotic prescriptions modified by general practitioners divided by the total number of initial antibiotic prescriptions'}], 'secondaryOutcomes': [{'measure': 'Rate of initial antibiotherapies not relevant to recommendations', 'timeFrame': '6 months', 'description': 'Number of initial antibiotic prescriptions not relevant to recommendations divided by the total number of initial antibiotic prescriptions'}, {'measure': 'Rate of initial antibiotherapies not consistent with recommendations', 'timeFrame': '6 months', 'description': 'Number of initial antibiotic prescriptions not consistent (molecule, dose, period of time) with recommendations divided by the total number of initial antibiotic prescriptions'}, {'measure': 'Rate of reassessments not relevant to recommendations', 'timeFrame': '6 months', 'description': 'Number of antibiotic prescription modifications not relevant to recommendations divided by the total number of antibiotic prescription modifications'}, {'measure': 'Rate of reassessments not consistent with recommendations', 'timeFrame': '6 months', 'description': 'Number of antibiotic prescription modifications not consistent (molecule, dose, period of time) with recommendations divided by the total number of antibiotic prescription modifications'}, {'measure': 'Frequence of use of shared medical file', 'timeFrame': '6 months', 'description': 'Number of patients for which the shared medical file is used divided by the total number of patients enrolled'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urinary infections', 'Antibiotherapy', 'Emergency', 'Reassessment'], 'conditions': ['Urinary Tract Infections']}, 'descriptionModule': {'briefSummary': 'Urinary infections are at the origin of many emergency department consultations and antibiotic prescriptions. Increase of bacteria resistance to antibiotics is promoted by an inappropriate use of those antibiotics but initial prescription in emergency departments is complicated by brief clinical examinations, unavailable sampling results and risks of multi-resistant bacteria. Large diffusion of new recommendations for urinary infection management should improve the quality of initial antibiotic prescription. However emergency physicians have no knowledge of the reassessment of antibiotherapy 48 to 72 hours after initial prescription by general practitioners which is a quality criterion of good antibiotic use. The main purpose of this study is to estimate the reassessment rate by general practitioners of the urinary infection antibiotherapies prescribed in emergency departments. This will allow assessing the quality of initial antibiotic prescription and help to improve practices.', 'detailedDescription': "Urinary infections are at the origin of many emergency department consultations and antibiotic prescriptions. Increase of bacteria resistance to antibiotics is promoted by an inappropriate use of those antibiotics but initial prescription in emergency departments is complicated by brief clinical examinations, unavailable sampling results and risks of multi-resistant bacteria. Large diffusion of new recommendations for urinary infection management should improve the quality of initial antibiotic prescription. However emergency physicians have no knowledge of the reassessment of antibiotherapy 48 to 72 hours after initial prescription by general practitioners which is a quality criterion of good antibiotic use. The main purpose of this study is to estimate the reassessment rate by general practitioners of the urinary infection antibiotherapies prescribed in emergency departments.\n\nPatients will be informed during their consultation in one of Toulon - La Seyne sur Mer hospital emergency departments. If they don't express opposition to their data collection, they will be included. A form will then be completed by emergency physicians with initial prescribed antibiotherapy, patients' general practitioners contact information and if patients have a shared medical file or not. 4 to 5 days later, patients' general practitioners will be contacted to know if urinary analysis results were transferred from emergency department to practitioners, if antibiotherapy was modified and if patients' shared medical file was consulted."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients consulting in emergency departments of Toulon La Seyne sur Mer hospital because of a urinary infection and to whom antibiotherapy is prescribed', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Every patient more than 18 years who was administered antibiotherapy for urinary infection in emergency department or for whom urinary infection was diagnosed in emergency department (cystitis, acute pyelonephritis, prostatitis)\n\nExclusion Criteria:\n\n* Patients less than 18 years old\n* Patients opposed to their data use\n* Patients hospitalized more than 24 hours\n* Patients taking antibiotherapy already before their arrival in emergency department\n* Patients without sufficient reading capacities or understanding of french language to express opposition to their research participation\n* Any other reason which, according to investigator, might interfere with research objective evaluation'}, 'identificationModule': {'nctId': 'NCT03928951', 'acronym': 'ATB-IU', 'briefTitle': 'General Practitioner Reassessment of Urinary Infection Antibiotherapy Prescribed by Emergency Departments', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer'}, 'officialTitle': 'General Practitioner Reassessment of the Antibiotherapy of Urinary Infections Initially Treated in Emergency Departments', 'orgStudyIdInfo': {'id': '2019-CHITS-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients suffering from urinary infection', 'description': 'Patients consulting in one of Toulon - La Seyne sur Mer hospital emergency departments because of urinary infection', 'interventionNames': ['Other: General practitioner reassessment of urinary infection antibiotherapy prescribed by emergency departments']}], 'interventions': [{'name': 'General practitioner reassessment of urinary infection antibiotherapy prescribed by emergency departments', 'type': 'OTHER', 'description': 'Antibiotherapy will be prescribed by emergency physicians and general practitioners will be contacted 4 to 5 days later to know if antibiotherapy was modified', 'armGroupLabels': ['Patients suffering from urinary infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83056', 'city': 'Toulon', 'state': 'Var', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}], 'overallOfficials': [{'name': 'Mouna EL OMRI, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}