NCT05919550已完成不适用
Clozapine-associated Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26,815,616
- 试验地点
- 1
- 主要终点
- Correlation between clozapine and hinfections using a disproportionality analysis in Individual Case Reports involving at least one liable antipsychotic drug in Vigibase®
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Chronology not compatible between the drug and the toxicity
研究组 & 干预措施
Patients presenting a possible drug-induced adverse effects
干预措施: search for a clozapine intake (Drug)
结局指标
主要结局
Correlation between clozapine and hinfections using a disproportionality analysis in Individual Case Reports involving at least one liable antipsychotic drug in Vigibase®
时间窗: from the 01/01/1963 to the 11/04/2023
次要结局
- 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)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
4 期
Clozapine-related Immunodeficiency in Parkinsons DiseaseClozapineParkinson's Disease (PD)PsychosisImmunodeficiencyNCT06634641Centre Hospitalier Universitaire, Amiens24
已完成
不适用
Identification of a risk factor for clozapine-induced sialorrheaschizophreniaJPRN-UMIN000026822Hokkaido University Hospital30
已完成
不适用
Biomarker and Safety Study of Clozapine in Patients With Benign Ethnic Neutropenia (BEN)SchizophreniaNCT02404155University of Maryland, Baltimore274
Unknown
不适用
Phenomics and Genomics of Clozapine PharmacotherapySchizophrenia Spectrum and Other Psychotic DisordersNCT03253367Jurjen Luykx2,500
已完成
4 期
Effectiveness of Aripiprazole for Improving Side Effects of Clozapine in the Treatment of People With SchizophreniaInsulin ResistanceSchizophreniaNCT00345033Massachusetts General Hospital38