NCT00082524已完成2 期
A Multicenter, Open-Label, Noncomparative Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Acetate in Children With Documented Candida or Aspergillus Infections
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- The proportion of patients with one or more drug-related clinical or laboratory adverse experience(s)
研究概览
简要总结
This study is an open label, noncomparative study using an investigational agent for the treatment of documented Candida or Aspergillus infections in pediatric patients (ages 3 months-17 years).
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
- 3 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The proportion of patients with one or more drug-related clinical or laboratory adverse experience(s)
次要结局
- The proportion of patients with a favorable efficacy response to caspofungin therapy in each infection type
- The proportion of patients who discontinued due to a drug-related AE or who have a serious drug-related AE
研究者
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