NCT00531479已完成3 期
A Prospective, Randomized Trial Comparing The Efficacy Of Anidulafungin And Voriconazole In Combination To That Of Voriconazole Alone When Used For Primary Therapy Of Proven Or Probable Invasive Aspergillosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 459
- 试验地点
- 1
- 主要终点
- All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis
研究概览
简要总结
This study compares the effectiveness and safety of the combination of anidulafungin and voriconazole compared to that of voriconazole alone (which is generally considered the standard of care) for the treatment of 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Immunocompromised state due to either
- •receipt of hematopoeitic stem cell transplantation or
- •hematologic malignancy;
- •Diagnosis of possible, probable, or proven invasive aspergillosis.
排除标准
- •Patients with aspergilloma or chronic aspergillosis
- •Receipt of 4 or more days of systemic antifungal treatment for the current episode of invasive aspergillosis
- •Anticipated survival of less than 5 days or Karnofsky score <=20
研究组 & 干预措施
Voriconazole
Active Comparator
Voriconazole monotherapy
干预措施: voriconazole (Drug)
Voriconazole and Anidulafungin
Experimental
Combination therapy with voriconazole and anidulafungin
干预措施: anidulafungin (Drug)
Voriconazole and Anidulafungin
Experimental
Combination therapy with voriconazole and anidulafungin
干预措施: voriconazole (Drug)
结局指标
主要结局
All-cause Mortality at Week 6 in Participants With Proven or Probable Invasive Aspergillosis
时间窗: Day 1 to Day 42 (Week 6)
Number of deaths measured 6 weeks after start of treatment. Time to death defined as date of death minus first treatment date + 1.
次要结局
- Global Response at Week 6(Baseline, Day 42 (Week 6))
- All-cause Mortality at Week 6 in Participants With Possible, Probable, or Proven Invasive Aspergillosis (IA)(Day 1 to Day 42 (Week 6))
- All-cause Mortality at Week 12 in Participants With Probable or Proven Invasive Aspergillosis (IA)(Day 1 to Day 84 (Week 12))
- Mortality Due to Invasive Aspergillosis (IA) at Week 6 in Participants With Probable or Proven IA(Day 1 to Day 42 (Week 6))
- Time to Death: All-Cause Mortality(Day 1 to Day 84 (Week 12))
- Time to Death Due to Invasive Aspergillosis (IA)(Day 1 to Day 84 (Week 12))
研究者
研究点 (1)
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