NCT00143312已完成4 期
Prospective, Open-Label, Non-Comparative, Multicenter Study for the Secondary Prophylaxis of Invasive Fungal Infections (IFI) With Voriconazole in Patients With Allogeneic Stem Cell Transplants (SCT).
适应症
干预措施
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
- 45
- 试验地点
- 1
- 主要终点
- Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit
研究概览
简要总结
To prevent recurrence of invasive fungal infection in patients with allogeneic stem cell transplants
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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with proven or probable IFI in previous 12 months receiving an allogenic stem cell transplant for any haematological disease
排除标准
- •Pregnant or lactating women
- •Severe disease other tham the underlying condition
- •Active, symptomatic uncontrolled Invasive Fungal Infection
- •Any evidence of active fungal disease as defined by MSG-EORTC criteria
- •Concomitant use of Voriconazole 36 hours before chemotherapy until 48 hours after chemotherapy
- •Other medical conditions, including HIV positive serology that would interfere with the evaluation of therapeutic response or safety of study drug
研究组 & 干预措施
1
Experimental
干预措施: voriconazole (Drug)
结局指标
主要结局
Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit
时间窗: 12 months
Number of participants developing a proven or probable IFI from start of voriconazole prophylaxis until 12-month follow up
次要结局
- Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 6-month Follow-up Visit(6 months)
- Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Voriconazole Prophylaxis Until End of Prophylaxis Visit(150 days)
- Time to Occurrence of Proven or Probable Invasive Fungal Infection (IFI)(12 months)
- Time to Occurrence of Proven or Probable New (New Pathogen) Invasive Fungal Infection (IFI)(12 months)
- Time to Occurrence of Proven or Probable Recurrent Invasive Fungal Infection (IFI) (Same Pathogen as Previous Baseline IFI)(12 months)
- Survival Without Proven or Probable Invasive Fungal Infection (IFI)(6 months, 12 months)
研究者
研究点 (1)
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