NCT00330395已完成2 期
A Multicenter, Sequential-Panel, Open-Label, Noncomparative Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Caspofungin Acetate in Neonates and Infants Less Than 3 Months of Age.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Pharmacokinetic parameters of drug exposure
研究概览
简要总结
The purpose of this study is to test the amount of caspofungin found in the blood of neonate and infants <3 months of age following treatment with caspofungin at 25 mg/m2. Another purpose is to test the safety of caspofungin in treating neonates and infants with Candida infections (a certain type of fungal infection).
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
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates and infants <3 months of age
- •Patient has a body weight greater than or equal to 500 grams
- •Patient has documented or highly suspected Candida infection
排除标准
- •Patient is greater than 3 months of age
- •Patient has a body weight of less than 500 grams
- •Patient does not meet certain laboratory testing criteria
- •Patient is hemodynamically unstable, exhibits hemodynamic compromise or is not expected to survive at least 5 days
- •Patient has documented HIV infection of any stage
- •Patient has a history of allergy, hypersensitivity, or serious reaction to caspofungin or another member of the echinocandin class
结局指标
主要结局
Pharmacokinetic parameters of drug exposure
次要结局
- Safety and tolerability
研究者
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