Clozapine-associated Infection

Caen University Hospital

Status: Completed

Conditions: Infections

Treatments: Drug: search for a clozapine intake

Study type: Observational

Funder types: Other

Identifiers

NCT05919550

Clozinfection

Details and patient eligibility

About

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.

Enrollment: 26,815,616 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

26,815,616 participants in 1 patient group

Patients presenting a possible drug-induced adverse effects

Treatment:

Drug: search for a clozapine intake