Observational, Longitudinal, Prospective, French, Multicentre Study Conducted on Adult and Paediatric Patients Treated With Micafungin in Prophylaxis and Followed Over a 3 Months' Period in Routine Medical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Breakthrough incidence of Invasive Fungal Infection (IFI), defined according to the revised EORTC/MSG criteria, during prophylaxis use of micafungin
研究概览
简要总结
The purpose of this observational study is to describe the actual conditions of prescription of micafungin in antifungal prophylaxis in French haematological and onco-haematological units. The efficacy and the safety outcomes will be described.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient with haemopathy or paediatric patients with haemopathy or solid tumor.
- •Patient hospitalized in haematology, onco-haematology or onco-paediatrics unit.
- •Patient initiating antifungal prophylaxis with micafungin.
排除标准
- •Patient presenting documented fungal infection.
- •Patient already included in a biomedical study impacting the care management of invasive fungal infection at the time of inclusion.
研究组 & 干预措施
Micafungin
Patients affected with haemopathy (or affected with solid tumor for paediatric patients) under antifungal prophylaxis with micafungin.
干预措施: Micafungin (Drug)
结局指标
主要结局
Breakthrough incidence of Invasive Fungal Infection (IFI), defined according to the revised EORTC/MSG criteria, during prophylaxis use of micafungin
时间窗: Up to 3 months
EORTC/MSG : European Organization for Research and Treatment of Cancer/ Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group
次要结局
- Description of adverse events (AE) and serious adverse events (SAE)(Up to 3 months)
- Odds ratio and 95% CI for each identified risk factors(Up to 3 months)
- Incidence of IFI, defined according to the revised EORTC/MSG criteria(Up to 3 months)
- Characteristics of patients treated with micafungin(Day 0 (start of prophylaxis))
- Characteristics of units(Day 0)
- Conditions of use of micafungin(Up to 3 months)