Infections
Conditions
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.
Interventions
DRUGsearch for a clozapine intake
search for a clozapine intake
Sponsors
University Hospital, Caen
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed