A Phase 3, Randomized, Double-Blind, Comparative Study of Micafungin (FK463) Versus Caspofungin as Antifungal Treatment in Patients With Invasive Candidiasis or Candidemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 611
- 主要终点
- Overall treatment success, based on the investigator's assessment of pre-defined clinical and mycological response at the End of intravenous (IV) Therapy
研究概览
简要总结
The purpose of the study is to determine the safety and effectiveness of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia.
详细描述
The purpose of the study is to determine the efficacy and safety of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia. The maximum length of antifungal treatment is 4 weeks except in pre-defined patients where maximum length of therapy is 8 weeks. A post treatment assessment will be conducted at 2 weeks and 6 weeks after the last dose of all antifungal treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Patients must have candidemia or invasive candidiasis.
排除标准
- •Patients who have received an echinocandin within one month prior to study entry.
- •Patients who have received more than two days of prior systemic antifungal therapy for the current infection.
研究组 & 干预措施
1
lower dose
干预措施: Micafungin (Drug)
2
higher dose
干预措施: Micafungin (Drug)
3
干预措施: Caspofungin (Drug)
结局指标
主要结局
Overall treatment success, based on the investigator's assessment of pre-defined clinical and mycological response at the End of intravenous (IV) Therapy
时间窗: End of therapy and 6 weeks post-treatment
次要结局
- Overall treatment success, based on the Data Review Panel's assessment of pre-defined clinical and mycological response at the End of IV Therapy(End of therapy and 6 weeks post-treatment)