NCT00666185已完成3 期
A Phase 3, Randomized, Double-Blind, Comparative Trial of Micafungin Versus Fluconazole for the Treatment of Esophageal Candidiasis
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
- 523
- 试验地点
- 5
- 主要终点
- Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy
研究概览
简要总结
To determine the efficacy and safety of IV Micafungin versus IV Fluconazole in the treatment of patients with 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
- •Diagnosis of esophageal candidiasis confirmed by endoscopy
- •Negative pregnancy test in females of childbearing potential
排除标准
- •Pregnant or nursing
- •Evidence of liver disease
- •Presence of 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
- •Receipt of an oral or topical antifungal agent within 48 hours or a systemic agent within 72 hours of first dose of study drug
- •Non-responsive to therapy in any prior systemic antifungal clinical trail
- •History of > 2 episodes of esophageal candidiasis requiring systemic antifungal therapy
- •History of anaphylaxis attributed to azole compounds or echinocandin class of antifungals
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
Endoscopic cure rate, defined as a mucosal grade of zero at the end of the therapy
时间窗: End of Therapy
次要结局
- Clinical response at end of therapy of cleared or improved(End of Therapy)
- Mucosal response at end of therapy of cleared or improved(End of Therapy)
研究者
研究点 (5)
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