NCT02214771已完成不适用
Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients (DAFNE Study)
Astellas Pharma S.A.S.1 个研究点 分布在 1 个国家目标入组 296 人开始时间: 2014年9月3日最近更新:
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
- 发起方
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- Characteristics of the CDI treated with fidaxomicin, including date of CDI diagnosis, department requesting the diagnosis of CDI, methods used, severity of CDI and origin of the case
研究概览
简要总结
The study aims to describe the characteristics and the methods of management and follow-up of patients treated with fidaxomicin for Clostridium difficile infection (CDI).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patient
- •Patient diagnosed with CDI
排除标准
- •Patient already included in this study
- •Patient is taking part in a clinical trial in the field of CDI
研究组 & 干预措施
1: CDI in patients treated with fidaxomicin
Diagnosed with a CDI and treated with fidaxomicin
干预措施: Fidaxomicin (Drug)
2: CDI in patients receiving treatment other than fidaxomicin
Diagnosed with a CDI, regardless of the prescribed treatment (not fidaxomicin)
干预措施: Treatment for CDI other than fidaxomicin Type (Drug)
结局指标
主要结局
Characteristics of the CDI treated with fidaxomicin, including date of CDI diagnosis, department requesting the diagnosis of CDI, methods used, severity of CDI and origin of the case
时间窗: Day 1
Characteristics of patients treated with fidaxomicin, including demographic data, description of comorbidities and treatment by antibiotherapy
时间窗: Day 1
次要结局
- Characteristics of patients diagnosed with CDI, including demographic data and treatment by antibiotherapy(Day 1)
- Therapeutic management of the CDI, including the starting date of the treatment, CDI treatment first line and associated treatment(Day 1)
- Number and timing of recurrences in patients treated with fidaxomicin over a 3-month follow-up period(End of the follow-up (3 months))
- Adverse events and serious adverse events occurring on fidaxomicin(End of the follow-up (3 months))
- Characteristics of the CDI, including date of CDI diagnosis, Department requesting the diagnosis of CDI, methods used, severity of CDI and origin of the case(Day 1)
- Treatment of the CDI including treatment selected and dosage(Day 1)
研究者
研究点 (1)
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