A Prospective, Randomized Trial Comparing The Safety, Tolerability, And Efficacy Of Voriconazole And Anidulafungin In Combination To That Of Voriconazole Alone When Used For Primary Therapy Of Invasive Aspergillosis in Pediatric Subjects Aged 2 to 17 Years
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Safety and tolerability of voriconazole and anidulafungin in combination versus voriconazole alone as determined by rates of adverse events
研究概览
简要总结
This study aims to compare the safety, tolerability, and efficacy of voriconazole and anidulafungin in combination versus voriconazole alone in pediatric subjects aged 2 to 17 years with invasive aspergillosis.
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
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of proven, probable, or possible invasive aspergillosis.
- •Hematologic malignancy or allogeneic hematopoetic stem cell transplant.
排除标准
- •Sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
- •Chronic invasive aspergillosis.
- •Receipt of antifungal treatment for more than 96 hours.
- •Severe liver dysfunction.
研究组 & 干预措施
Voriconazole Monotherapy
Subjects in the monotherapy arm will receive voriconazole monotherapy for 6-12 weeks of therapy.
干预措施: Voriconazole (Drug)
Voriconazole and Anidulafungin Combination
Subjects in the combination arm will receive voriconazole and anidulafungin in combination for 2-4 weeks followed by voriconazole monotherapy to complete 6-12 weeks of therapy.
干预措施: Voriconazole (Drug)
Voriconazole and Anidulafungin Combination
Subjects in the combination arm will receive voriconazole and anidulafungin in combination for 2-4 weeks followed by voriconazole monotherapy to complete 6-12 weeks of therapy.
干预措施: Anidulafungin (Drug)
结局指标
主要结局
Safety and tolerability of voriconazole and anidulafungin in combination versus voriconazole alone as determined by rates of adverse events
时间窗: 12 weeks
次要结局
- Global response to therapy at 6 weeks(6 weeks)
- Rate of all-cause mortality at 6 weeks(6 weeks)
- Rate of all-cause mortality at EOT(12 weeks)
- Global response to therapy at EOT(12 weeks)