NCT00548080已完成3 期
A Non-Comparative, Multicenter, Open-Label, Study to Evaluate the Safety and Efficacy of Caspofungin Acetate as Empirical Therapy in Chinese Adults With Persistent Fever and Neutropenia
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 131
- 主要终点
- The proportion of caspofungin-treated patients with SAE
研究概览
简要总结
Registration study
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has had an absolute neutrophil count < 500/mm3 for at least 96 hours (the patient must not be expected to recover from neutropenia in the next 48 hours), and has received at least 96 hours of parenteral broad spectrum systemic antibacterial therapy preceding study entry, and patient has fever >38.0 Degrees Centigrade within the last 24 hours prior to study entry
- •Appropriate antibiotics are those that provide broad spectrum gram-positive and gram-negative coverage
排除标准
- •Patient has an inadequately managed bacterial infection at the time of enrollment
结局指标
主要结局
The proportion of caspofungin-treated patients with SAE
次要结局
- The proportion of caspofungin-treated patients with a favorable efficacy response at the end of caspofungin study therapy
研究者
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