Clozapine-associated Infection
Completed
- Conditions
- Infections
- Interventions
- Drug: search for a clozapine intake
- Registration Number
- NCT05919550
- Lead Sponsor
- University Hospital, Caen
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26815616
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients presenting a possible drug-induced adverse effects search for a clozapine intake -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method investigate a potential dose-dependent effect from the 01/01/1963 to the 11/04/2023 A logistical regression model will be applied to search for a dose-dependant effect of infection using clozapine quartile doses.
Description of the clinical features of clozapine-related infections from the 01/01/1963 to the 11/04/2023 Description of age, sex, time to onset, type of infections using MedDRA
Trial Locations
- Locations (1)
Caen University Hospital, Department of Pharmacology
🇫🇷Caen, Normandie, France