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.

Study Overview

• Status: Completed
• Conditions: Infections
• Intervention / Treatment: Drug: search for a clozapine intake

• Study Type: Observational
• Enrollment (Actual): 26815616

Contacts and Locations

Study Locations

• France
  • Normandie
    • Caen, Normandie, France, 14033
      • Caen University Hospital, Department of Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with a possible drug-induced adverse effect

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients presenting a possible drug-induced adverse effects	Drug: search for a clozapine intake; search for a clozapine intake

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2023
• Primary Completion (Actual): April 11, 2023
• Study Completion (Actual): April 11, 2023

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: June 23, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; GABA Agents; GABA Antagonists; Clozapine
• Other Study ID Numbers: Clozinfection

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No