NCT00665639已完成3 期
A Phase 3, Randomized, Double-Blind, Comparative Trial of Two Dosing Regimens of Micafungin (FK463) Versus Caspofungin for the Treatment of Esophageal Candidiasis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 454
- 试验地点
- 5
- 主要终点
- Comparative incidence of success, defined as complete clearing of esophageal lesions
研究概览
简要总结
To determine the efficacy and safety of daily doses of IV micafungin versus IV caspofungin for the treatment of esophageal candidiasis
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
- Triple (Participant, Care Provider, Investigator)
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
- •Esophageal candidiasis confirmed by endoscopy
- •Negative pregnancy test for female patients of childbearing potential
排除标准
- •Pregnant or nursing female patient
- •Evidence of liver disease
- •Another active opportunistic fungal infection and/or receiving acute systemic therapy for an opportunistic fungal infection
- •Concomitant esophagitis caused by herpes simplex virus or cytomegalovirus
- •Received an oral or topical antifungal agent within 48 hours or a systemic antifungal agent within 72 hours of first dose of study drug
- •Known to be non-responsive to therapy in any prior systemic antifungal clinical trail
- •Experienced > 2 episodes of esophageal candidiasis requiring systemic antifungal therapy
- •History of anaphylaxis attributed to echinocandin class of antifungals
研究组 & 干预措施
1
Experimental
Daily dose
干预措施: micafungin (Drug)
2
Active Comparator
干预措施: caspofungin (Drug)
3
Experimental
Every other day dose, alternating with placebo
干预措施: micafungin (Drug)
结局指标
主要结局
Comparative incidence of success, defined as complete clearing of esophageal lesions
时间窗: End of Therapy
次要结局
- Clinical response(End of Therapy)
- Mycological response(End of Therapy)
- Overall therapeutic response(End of Therapy)
研究者
研究点 (5)
Loading locations...
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