NCT00288197已完成4 期
An Open, Prospective, Uncontrolled, Multi-Center Study To Evaluate The Efficacy And Safety Of Voriconazole In Chinese Subjects With Proven Or Probable Serious Invasive Fungal Infections
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 77
- 试验地点
- 10
- 主要终点
- Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" by Week 6 visit.
研究概览
简要总结
To evaluate the efficacy and safety of voriconazole in Chinese patients with proven or probable deep tissue fungal infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with proven or probable invasive fungal infections including subjects who have failed to respond to, or have an intolerance to other approved antifungal treatments and with approval for salvage treatment by Principal Investigator and Pfizer.
排除标准
- •Subjects who are showing continuing improvement with other antifungal agents, including amphotericin B, itraconazole, nystatin, fluconazole, flucytosine and miconazole.
- •Subjects with an invasive fungal infection caused by a fungus (such as Mucor) that is not in the antifungal spectrum of voriconazole.
结局指标
主要结局
Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" by Week 6 visit.
次要结局
- Safety assessment during the study period (Adverse events observed between start of treatment and follow-up visit).
- Percent of subjects with a Global Efficacy assessment of either "cured" or "improved" at the time when IV administration is completed
研究者
研究点 (10)
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