NCT00189709已完成3 期
A Single Center, Open, Parallel, Comparative, Randomized Study of Micafungin (FK463) vs Fluconazole (Diflucan) in the Treatment of Invasive Candidiasis and Candidaemia (Protocol No: MCFGCAN-0301F-TW)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Response rate
研究概览
简要总结
To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in treating patients with invasive candidiasis or candidaemia
详细描述
Micafungin (a new class of antifungal drugs) is compared to fluconazole (current standard treatment) in the treatment of patients with serious fungal infections (invasive candidiasis and candidemia) to determine its efficacy and safety. Patients, both male and female, aged over 16 and with confirmed disease by the doctor could be recruited and evaluated.
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
- None
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
- •Patients with a confirmed diagnosis of candidemia and invasive candidiasis
- •Patients could be newly diagnosed with candidiasis who received no more than 48 hours of prior systemic antifungal therapy
- •Inpatients aged 16 and above
排除标准
- •Patients with serious invasive candidiasis whose prognoses are considered to be poor (life expectancy judged to be less than 5 days).
- •Patients with severe complications in the liver
- •Pregnant or lactating women
- •Patients who have received at least 5 days of prior systemic treatment of fluconazole or echinocandin with no response.
- •Patients who have prior antifungal infection requiring treatment with systemic antifungal agents for conditions other than candidemia and invasive candidiasis.
研究组 & 干预措施
1
Experimental
干预措施: Micafungin (Drug)
2
Active Comparator
干预措施: fluconazole (Drug)
结局指标
主要结局
Response rate
时间窗: 2-8 Weeks
次要结局
- Clinical response, mycological response(2-8 weeks)
研究者
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