Clozapine-associated Infection

• Sponsor: University Hospital, Caen (Other)
• Overall Status: Completed
• CT.gov ID: NCT05919550
• Collaborator: (none)
• Enrollment: 26,815,616
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infections	Drug: search for a clozapine intake

Study Design

• Study Type: Observational
• Actual Enrollment: 26815616 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Clozapine-associated Infection
• Actual Study Start Date: Apr 11, 2023
• Actual Primary Completion Date: Apr 11, 2023
• Actual Study Completion Date: Apr 11, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Caen University Hospital, Department of Pharmacology	Caen	Normandie	France	14033

Sponsors and Collaborators

• University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Caen
• ClinicalTrials.gov Identifier: NCT05919550
• Other Study ID Numbers: Clozinfection
• First Posted: Jun 26, 2023
• Last Update Posted: Jun 26, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Clozapine

Study Results

No Results Posted as of Jun 26, 2023