Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT03768635
Status:
COMPLETED
Last Update Posted:
2018-12-11
First Post:
2018-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Necrotizing External Otitis : Study in a Regional Bone and Joint Infection Reference Center
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010031', 'term': 'Otitis'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-07', 'studyFirstSubmitDate': '2018-12-05', 'studyFirstSubmitQcDate': '2018-12-05', 'lastUpdatePostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of necrotizing external otitis', 'timeFrame': 'Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption', 'description': 'description of necrotizing external otitis: patients, profile of the bacterium, medical and chirurgical treatment, rate'}], 'secondaryOutcomes': [{'measure': 'Rate of Treatment Failure', 'timeFrame': 'Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption', 'description': 'Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin. Analyse of risk factor.'}, {'measure': 'Duration of antibiotics', 'timeFrame': 'Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption', 'description': 'Description of the strategies of antibiotic treatments used (double-agent therapy, monotherapy, duration)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['otitis'], 'conditions': ['Bone and Joint Infection']}, 'descriptionModule': {'briefSummary': 'The malignant external otitis is a rare disease which arises more frequently at the elderly and the diabetics patients. To our knowledge, there are few data and it is not wellc known byclinicians. Nevertheless it exposes to neurological complications potentially serious and crippling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients having had necrotizing external otitis and managed at the Lyon Bone and joint infection refence Center between 01/01/2006 and 31/01/2018', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients having had necrotizing external otitis and managed at the Lyon Bone and joint infection refence Center\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03768635', 'briefTitle': 'Necrotizing External Otitis : Study in a Regional Bone and Joint Infection Reference Center', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Necrotizing External Otitis : Study in a Regional Bone and Joint Infection', 'orgStudyIdInfo': {'id': '18-284'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Necrotizing external otitis', 'description': 'description of necrotizing external otitis', 'interventionNames': ['Other: necrotizing external otitis']}], 'interventions': [{'name': 'necrotizing external otitis', 'type': 'OTHER', 'description': 'description of necrotizing external otitis', 'armGroupLabels': ['Necrotizing external otitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Tristan Ferry, Md, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Reseacrh Assistant', 'investigatorFullName': 'Eugénie MABRUT', 'investigatorAffiliation': 'Hospices Civils de Lyon'}}}}