Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2026-04-01 @ 11:30 AM
Study NCT ID:
NCT05919550
Status:
COMPLETED
Last Update Posted:
2023-06-26
First Post:
2023-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clozapine-associated Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26815616}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-23', 'studyFirstSubmitDate': '2023-04-26', 'studyFirstSubmitQcDate': '2023-06-23', 'lastUpdatePostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between clozapine and hinfections using a disproportionality analysis in Individual Case Reports involving at least one liable antipsychotic drug in Vigibase®', 'timeFrame': 'from the 01/01/1963 to the 11/04/2023'}], 'secondaryOutcomes': [{'measure': 'investigate a potential dose-dependent effect', 'timeFrame': 'from the 01/01/1963 to the 11/04/2023', 'description': 'A logistical regression model will be applied to search for a dose-dependant effect of infection using clozapine quartile doses.'}, {'measure': 'Description of the clinical features of clozapine-related infections', 'timeFrame': 'from the 01/01/1963 to the 11/04/2023', 'description': 'Description of age, sex, time to onset, type of infections using MedDRA'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infections']}, 'descriptionModule': {'briefSummary': 'perform a study in VigiBase® to assess if clozapine was associated with an over-reporting of infections and to characterize those infections. The investigators also decided to assess the dose dependency associated with those infections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a possible drug-induced adverse effect', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Case reported in the World Health Organization (WHO) database of individual safety case reports to 11/04/2023\n* Adverse events reported were including the MedDRA terms: infections (SOC)\n\nExclusion Criteria:\n\nChronology not compatible between the drug and the toxicity'}, 'identificationModule': {'nctId': 'NCT05919550', 'briefTitle': 'Clozapine-associated Infection', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Clozapine-associated Infection', 'orgStudyIdInfo': {'id': 'Clozinfection'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients presenting a possible drug-induced adverse effects', 'interventionNames': ['Drug: search for a clozapine intake']}], 'interventions': [{'name': 'search for a clozapine intake', 'type': 'DRUG', 'description': 'search for a clozapine intake', 'armGroupLabels': ['Patients presenting a possible drug-induced adverse effects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14033', 'city': 'Caen', 'state': 'Normandy', 'country': 'France', 'facility': 'Caen University Hospital, Department of Pharmacology', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}