Prospective, Open-Label, Comparative, Multi-Center Study Of Voriconazole Compared To Itraconazole For The Primary Prophylaxis Of Invasive Fungal Infection (IFI) With Allogeneic Hematopoietic Stem Cell Transplants (HSCT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 489
- 试验地点
- 1
- 主要终点
- Success at Day 180: Percent of Responders (Randomization Strata)
研究概览
简要总结
Study is to compare antifungal prophylaxis of Voriconazole and Itraconazole in subjects who have had a Stem Cell Transplant. The success of the end point will be measured using evidence of Infection, drug compliance and survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Allogeneic HSCT for acute leukemia (AML, ALL or myelodysplastic syndrome) failed lymphoma therapy or transformation of CML
- •Male and Female over 12 years or greater
排除标准
- •Possible, probable or proven IFI at study entry or at any time in 6 months prior to study entry, defined according to the 'consensus criteria' (Ascioglu et al 2002)
- •Previous history of zygomycosis
- •Anticipated survival less than one month
研究组 & 干预措施
Itraconazole
干预措施: Itraconazole (Drug)
Voriconazole
干预措施: Vfend - voriconazole (Drug)
结局指标
主要结局
Success at Day 180: Percent of Responders (Randomization Strata)
时间窗: Day 180 (Visit 9)
Percent of responders (by randomization strata) with success of antifungal prophylaxis at 180 days after allogeneic hematopoietic stem cell transplant (HSCT). Success: alive at Day 180 (Visit 9), had not developed a breakthrough proven or probable invasive fungal infection (IFI) by Visit 9, and received full course of study drug prophylaxis without interruption of greater than 14 days in total during the prophylaxis period; defined as failure if these criteria were not met. Additionally, if subject withdrew from study completely before Visit 9, imputed as failure at Visit 9 (programmatically).
次要结局
- Success at Day 100: Percent of Responders (Randomization Strata)(Day 100 (Visit 7))
- Time to Breakthrough Invasive Fungal Infection (IFI)(Day 1 up to Day 180 (Visit 9))
- Percent of Subjects With Occurrence of Breakthrough IFI(Day 1 up to Day 100 (Visit 7) and Day 180 (Visit 9))
- Survival: Percent of Subjects Who Died at or Before Day 180(Day 1 up to Day 180 (Visit 9))
- Time to Discontinuation of Study Treatment(Day 1 up to Day 180 (Visit 9))
- Survival: Percent of Subjects Who Died Within 1 Year(Day 1 up to 1 year (Day 365))
- Duration of Treatment(Day 1 up to Day 180)
- Percent of Subjects With Use of Other Systemic Antifungal Agents as Empirical or Therapeutic Treatment(Day 1 up to Day 180)