Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-28 @ 11:25 AM
Study NCT ID:
NCT04483232
Status:
UNKNOWN
Last Update Posted:
2020-07-23
First Post:
2020-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Achromobacter Spp: Description of Epidemiology and Resistance in Chronic Ear Infections and in Healthy Individuals.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-22', 'studyFirstSubmitDate': '2020-07-17', 'studyFirstSubmitQcDate': '2020-07-22', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Achromobacter positive sample number', 'timeFrame': 'Through study completion, an average of 3 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Achromobacter', 'Epidemiology', 'Chronic Ear Infection']}, 'descriptionModule': {'briefSummary': 'Hearing loss can be the result of chronic ear infections. The role of bacteria of the genus Achromobacter is not known in these conditions. An epidemiological study including a large number of patients is needed to compare the prevalence of these bacteria in sick and healthy subjects, and to highlight the characteristics of the strains and the factors favouring their emergence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Protected adult (curatorship, guardianship)\n* Person deprived of their liberty by judicial or administrative decision\n* Pregnant, parturient or breastfeeding woman\n* Adult unable to give consent\n* For healthy subjects:\n\n * current ear infection or within the last 6 months\n * Antibiotics (local or systemic) taken within the previous month\n* For sick subjects who have already been included once, new episode \\< 3 months after the previous one', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person or parent who has given his or her non-opposition\n* Person over 10 years of age\n* Sick Subjects Group :\n\ndiagnosis of chronic infection by an ENT specialist doctor if patient already included: new episode \\> 3 months after the complete clinical recovery from the previous episode observed by the ENT doctor - Healthy group: no ear infection in the last 6 months and no antibiotics in the previous month.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04483232', 'acronym': 'AERIO', 'briefTitle': 'Achromobacter Spp: Description of Epidemiology and Resistance in Chronic Ear Infections and in Healthy Individuals.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Achromobacter Spp: Description of Epidemiology and Resistance in Chronic Ear Infections and in Healthy Individuals.', 'orgStudyIdInfo': {'id': 'AMOUREUX FPA 2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Subjects', 'interventionNames': ['Biological: Ear canal swab']}, {'label': 'Patients with ear infections', 'interventionNames': ['Biological: Ear canal swab']}], 'interventions': [{'name': 'Ear canal swab', 'type': 'BIOLOGICAL', 'description': 'Ear canal swab', 'armGroupLabels': ['Healthy Subjects', 'Patients with ear infections']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'contacts': [{'name': 'Lucie AMOUREUX', 'role': 'CONTACT', 'email': 'lucie.amoureux@chu-dijon.fr', 'phone': '03.80.29.56.86', 'phoneExt': '+33'}], 'facility': 'Chu Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'centralContacts': [{'name': 'Lucie AMOUREUX', 'role': 'CONTACT', 'email': 'lucie.amoureux@chu-dijon.fr', 'phone': '03.80.29.56.86', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}