Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT05112367
Status:
UNKNOWN
Last Update Posted:
2021-11-08
First Post:
2021-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epidemiology and Management of Pediatric Anaphylaxis and Allergy in the Pediatric Emergency Department of Montpellier
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000707', 'term': 'Anaphylaxis'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D007154', 'term': 'Immune System 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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-27', 'studyFirstSubmitDate': '2021-10-27', 'studyFirstSubmitQcDate': '2021-10-27', 'lastUpdatePostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the management of pediatric anaphylaxis of allergy', 'timeFrame': 'day 1', 'description': 'Evaluation of the management of pediatric anaphylaxis of allergy in the pediatric emergency department of Montpellier University Hospital.'}, {'measure': 'Evaluation of the management of pediatric clinical signs evocative of allergy in the pediatric emergency department of Montpellier University Hospital.', 'timeFrame': 'day 1', 'description': 'Evaluation of the management of pediatric clinical signs evocative of allergy in the pediatric emergency department of Montpellier University Hospital.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of an appropriate use of epinephrine', 'timeFrame': 'day 1', 'description': 'Evaluation of an appropriate use of epinephrine'}, {'measure': 'Evaluation of an appropriate use of a possible follow-up of patients after the episode', 'timeFrame': 'day 1', 'description': 'Evaluation of an appropriate use of a possible follow-up of patients after the episode'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Children', 'Emergency', 'Epinephrine'], 'conditions': ['Anaphylaxis', 'Allergy']}, 'referencesModule': {'references': [{'pmid': '37632240', 'type': 'DERIVED', 'citation': 'Clark E, Kase Tanno L, Vo T, Blanc B, Demoly P, Caimmi D. Anaphylaxis management in a French pediatric emergency department: Lessons from the ANA-PED study. Clin Transl Allergy. 2023 Aug;13(8):e12289. doi: 10.1002/clt2.12289.'}]}, 'descriptionModule': {'briefSummary': 'Anaphylaxis is a severe life-threatening reaction following exposure to an antigen. Its incidence is progressively increasing in the general population over years, especially among children. The diagnosis can be difficult, and recommendations for follow up and prescription for an emergency kit are rarely provided after emergency visit. The Investigators will evaluate the management of pediatric anaphylaxis and clinical signs of allergy in the pediatric emergency department of Montpellier University Hospital'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children consulting in the paediatric emergency department of Montpellier for suspected allergy from 2016 to 2020', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients evaluated at the Montpellier University Hospital, Allergy Unit ;\n* Children consulting for suspected allergy from 2016 to 2020\n\nExclusion criteria:\n\n\\- Patients under legal protection, under guardianship or under curatorship;'}, 'identificationModule': {'nctId': 'NCT05112367', 'acronym': 'Ana-Ped', 'briefTitle': 'Epidemiology and Management of Pediatric Anaphylaxis and Allergy in the Pediatric Emergency Department of Montpellier', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Retrospective Study on the Management of Pediatric Anaphylaxis and Clinical Signs of Allergy in the Pediatric Emergency Department of Montpellier University Hospital', 'orgStudyIdInfo': {'id': 'RECHMPL21_0613'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Davide CAIMMI, MD', 'role': 'CONTACT', 'email': 'davide.caimmi@gmail.com', 'phone': '467336112', 'phoneExt': '33'}], 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Davide CAIMMI, MD', 'role': 'CONTACT', 'email': 'davide.caimmi@gmail.com', 'phone': '467336112', 'phoneExt': '33'}, {'name': 'Evangéline CLARK, doctor', 'role': 'CONTACT', 'email': 'e-clark@chu-montpellier.fr', 'phone': '467336107'}], 'overallOfficials': [{'name': 'Davide CAIMMI', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}