NCT00048750终止3 期
A Phase 3, Randomized,Double-Blind, Comparative Study of Micafungin (FK463) Versus Placebo as Preemptive Prophylactic Antifungal Therapy in Patients in the Intensive Care Unit
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 104
- 主要终点
- Assessment of the incidence of a proven or probable invasive fungal infection, catheter tip fungal infection, or deep incisional surgical site infection during the study
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of intravenous micafungin versus placebo as prophylactic therapy for invasive fungal infections in patients in the intensive care unit considered to be at high risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: Micafungin (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Assessment of the incidence of a proven or probable invasive fungal infection, catheter tip fungal infection, or deep incisional surgical site infection during the study
时间窗: Baseline through one week post-treatment
次要结局
- Assessment of the incidence of patients requiring alternative systemic antifungal therapy to treat suspected infection(Baseline through one week post-treatment)
研究者
相似试验
终止
4 期
Post Marketing Study to Evaluate the Efficacy and Safety of Micafungin Treatment on Invasive AspergillosisInvasive AspergillosisNCT02646774Astellas Pharma China, Inc.43
终止
4 期
Post Marketing Study to Evaluate the Safety and Efficacy of Micafungin Against Fungal Infections Caused by Candida Spp or Aspergillus SppCandidiasisAspergillosisNCT02646800Astellas Pharma China, Inc.105
终止
3 期
Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal CandidiasisCandidiasisNCT00815516Astellas Pharma Global Development, Inc.30
终止
2 期
Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for AspergillosisAspergillosisNCT00047827Astellas Pharma Inc2
已完成
3 期
Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal CandidiasisCandidiasis, OralNCT00666185Astellas Pharma Inc523