Clozapine-associated Infection

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.

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Key information

Conditions

Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

Caen University Hospital, Department of Pharmacology

Caen, Normandy, 14033, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

search for a clozapine intake

Drug

search for a clozapine intake

Primary outcomes

Correlation between clozapine and hinfections using a disproportionality analysis in Individual Case Reports involving at least one liable antipsychotic drug in Vigibase®

Time frame: from the 01/01/1963 to the 11/04/2023

Secondary outcomes

investigate a potential dose-dependent effect

Time frame: 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

Time frame: from the 01/01/1963 to the 11/04/2023

Description of age, sex, time to onset, type of infections using MedDRA

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Jun 26, 2023
Registry last updated: Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed