NCT05919550

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26,815,616

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
Last Updated

June 26, 2023

Status Verified

April 1, 2023

Enrollment Period

Same day

First QC Date

April 26, 2023

Last Update Submit

June 23, 2023

Conditions

Infections

Outcome Measures

Primary Outcomes (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 Outcomes (2)

  • investigate a potential dose-dependent effect

    from the 01/01/1963 to the 11/04/2023

  • Description of the clinical features of clozapine-related infections

    from the 01/01/1963 to the 11/04/2023

Study Arms (1)

Patients presenting a possible drug-induced adverse effects

Drug: search for a clozapine intake

Interventions

search for a clozapine intakeDRUG

search for a clozapine intake

Patients presenting a possible drug-induced adverse effects

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with a possible drug-induced adverse effect

You may qualify if:

  • 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)

You may not qualify if:

  • Chronology not compatible between the drug and the toxicity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital, Department of Pharmacology

Caen, Normandy, 14033, France

Location

MeSH Terms

Conditions

Infections

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2023

First Posted

June 26, 2023

Study Start

April 11, 2023

Primary Completion

April 11, 2023

Study Completion

April 11, 2023

Last Updated

June 26, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)