Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT03726632
Status:
COMPLETED
Last Update Posted:
2025-02-10
First Post:
2018-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Causality of Poisoning of the Elderly: Prospective Study Based on Data From the Poison Control Centre of Bordeaux
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011041', 'term': 'Poisoning'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2018-10-12', 'studyFirstSubmitQcDate': '2018-10-29', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nature of the agent', 'timeFrame': 'Baseline', 'description': 'The nature of the agent has to be chosen among (1 choice only): drug, chemical, household product, DIY product, phytosanitary product, gas, plant, foreign body, food'}], 'secondaryOutcomes': [{'measure': 'Circumstance of the event', 'timeFrame': 'Baseline', 'description': 'The circumstance of the event has to be chosen among (1 choice only): accidental / voluntary'}, {'measure': 'Exposition route of exposure', 'timeFrame': 'Baseline', 'description': 'The exposition route of exposure has to be chosen among (1 choice only): ingestion, eyepiece, dermal, inhalation or multiple routes'}, {'measure': 'symptoms', 'timeFrame': 'Baseline', 'description': 'Number / Nature'}, {'measure': 'Poisoning Severity', 'timeFrame': 'Baseline', 'description': 'The poisoning severity is evaluated using the Poisoning Severity Scale (PSS score). Severity grades: None (No symptoms or signs related to poisoning); MINOR (Mild, transient and spontaneously resolving symptoms); MODERATE (Pronounced or prolonged symptoms); SEVERE (Severe or life-threatening symptoms); DEATH'}, {'measure': 'Death', 'timeFrame': 'Baseline', 'description': 'death before the call'}, {'measure': 'Frailty status', 'timeFrame': 'Baseline', 'description': 'The frailty status is calculated from the following factors: sensory disturbance, cognitive and/or neurological disorder, psychiatric disorder, autonomy / dependence, concomittant treatments'}, {'measure': 'packaging of the agent', 'timeFrame': 'Baseline', 'description': 'The packaging of the agent has to be chosen among (1 choice only): solid, liquid, gaseous, powder and if drug: tablet, drops, syrup, patch, injectable'}, {'measure': 'Concomittant treatment', 'timeFrame': 'Baseline', 'description': 'Number of prescription drugs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elderly', 'Intoxication', 'Poison Control centre', 'Poisoning', 'Accidental exposure', 'Prevention'], 'conditions': ['Intoxication']}, 'descriptionModule': {'briefSummary': 'Elderly is often associated with social, physiological and psychic changes. However, no study has examined accidental poisoning-induced changes.\n\nThe objective of the study is to identify and analyze the various causes of potentially toxic accidental exposure of the elderly to determine preventable causes and propose prevention strategies.', 'detailedDescription': 'Elderly is often associated with social, physiological and psychic changes. Many studies tried to demonstrate their influence in the genesis of pathological events such as falls or suicide of the elderly but none on the genesis of accidental poisoning.\n\nHowever, poisoning in this age group is frequent and sometimes severe. In order to improve care of the elderly, it seems necessary to focus on potential toxic accidental exposure.\n\nFor this, Poison Control Centre of the University Hospital of Bordeaux has identified the causes over a period of 5 months (from 01 March to 31 July 2017) from calls to the centre.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All subjects aged 65 and over, victims of accidental or voluntary (excepted suicide) exposure of an agent (drug, household product, plant ...) and for who a call the Bordeaux Poison Control Centre has been called.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subjects aged 65 and over,\n* Victims of accidental exposure regardless of the agent (drug, household product, plant ...)\n* Victims of voluntary exposure (out of suicidal behavior)\n* And for which a call (notice, report) to the Poison Control Centre of Bordeaux has been recorded.\n* Calling dates between March 1st and July 31st, even if the exhibition is prior to March 1st, 2017).\n\nExclusion Criteria:\n\n* Suicide\n* Calls for inquiries'}, 'identificationModule': {'nctId': 'NCT03726632', 'acronym': 'GERIATOX', 'briefTitle': 'Causality of Poisoning of the Elderly: Prospective Study Based on Data From the Poison Control Centre of Bordeaux', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Causality of Poisoning of the Elderly: Prospective Study Based on Data From the Poison Control Centre of Bordeaux Over 5 Months', 'orgStudyIdInfo': {'id': 'CHUBX 2017/02'}}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': 'Centre Anti Poision du CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}