An Open Label, Non-comparative, Multicenter Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Serological response (evaluated by approved diagnostic serological tests [cryptococcosis, coccidiomycosis, and histoplasmosis]) at Weeks 2, 8, 12, and end of therapy.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Vfend for the treatment of 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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemic or invasive fungal infection
- •Infection caused by organism for which there is no current treatment or infection with evidence of failure and/or intolerance to treatment with approved antifungal agents
排除标准
- •Liver function test abnormalities
- •Renal disease
- •Fungal infections not considered to be invasive or systemic
研究组 & 干预措施
A
干预措施: Voriconazole (Drug)
结局指标
主要结局
Serological response (evaluated by approved diagnostic serological tests [cryptococcosis, coccidiomycosis, and histoplasmosis]) at Weeks 2, 8, 12, and end of therapy.
时间窗: Weeks 2, 8, 12, and end of therapy
Radiological response (evaluated based on all radiological abnormalities [X-ray, computed tomography scan] attributed to fungal infection compared to baseline) at Weeks 2, 8, 12, and end of therapy.
时间窗: Weeks 2, 8, 12, and end of therapy
Clinical response (evaluated based on change of attributable symptoms, signs, and/or bronchoscopic abnormalities present at baseline, judged by investigators, at Weeks 1, 2, 4, 8, 12, and end of therapy) at Weeks 1, 2, 4, 8, 12, and end of therapy.
时间窗: Weeks 1, 2, 4, 8, 12 and end of therapy
Mycological response (evaluated by the presences of fungal pathogen by relevant specimen [microscopy or histopathology]) at Weeks 2, 8, 12, and end of therapy.
时间窗: Weeks 2, 8, 12, and end of therapy
次要结局
- Change from baseline in electrocardiogram at Week 1 and end of therapy.(Week 1 and end of therapy)
- Visual safety testing at Weeks 1, 8, 12, end of therapy, Week 16, and follow-up.(Weeks 1, 8, 12, end of therapy, Week 16, and follow-up)
- Global response to treatment (incorporating clinical, mycological, radiological, and serological responses as applicable) at end of therapy/Week 16.(End of therapy or Week 16)
- Change from baseline in laboratory parameters at Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up.(Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up)
- Incidence of adverse events at Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up.(Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up)