Clozapine-associated Infection

NCT ID: NCT05919550

Last Updated: 2023-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26815616 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-11

Study Completion Date

2023-04-11

Brief Summary

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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.

Detailed Description

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Conditions

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Infections

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients presenting a possible drug-induced adverse effects

search for a clozapine intake

Intervention Type DRUG

search for a clozapine intake

Interventions

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search for a clozapine intake

search for a clozapine intake

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Caen University Hospital, Department of Pharmacology

Caen, Normandy, France

Site Status

Countries

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France

Other Identifiers

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Clozinfection

Identifier Type: -

Identifier Source: org_study_id

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