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NCT05919550 Clinical Trial

Clozapine-associated Infection

Infections Clinical Trial

Official title:
Clozapine-associated Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05919550
Other study ID # Clozinfection
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 11, 2023
Est. completion date April 11, 2023

Study information
Verified date April 2023
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 26815616
Est. completion date April 11, 2023
Est. primary completion date April 11, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Case reported in the World Health Organization (WHO) database of individual safety case reports to 11/04/2023 - Adverse events reported were including the MedDRA terms: infections (SOC) Exclusion Criteria: Chronology not compatible between the drug and the toxicity

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• search for a clozapine intake
search for a clozapine intake

Locations
Country Name City State
France Caen University Hospital, Department of Pharmacology Caen Normandie

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between clozapine and hinfections using a disproportionality analysis in Individual Case Reports involving at least one liable antipsychotic drug in Vigibase® from the 01/01/1963 to the 11/04/2023
Secondary investigate a potential dose-dependent effect A logistical regression model will be applied to search for a dose-dependant effect of infection using clozapine quartile doses. from the 01/01/1963 to the 11/04/2023
Secondary Description of the clinical features of clozapine-related infections Description of age, sex, time to onset, type of infections using MedDRA from the 01/01/1963 to the 11/04/2023
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