NCT01683760已完成2 期
Pharmacokinetic Study of Fluconazole in Premature Infants
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- drug level of fluconazole
研究概览
简要总结
The purpose of this study is to investigate the pharmacokinetics of fluconazole which is used as prophylaxis of invasive fungal infection in premature infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- — 至 4 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •very low birth weight infant (birth weight < 1,500 g) who were admitted to the NICU before day 3 of life
- •Informed consent from the parents
排除标准
- •Major congenital anomaly
- •Expired within 72 hours of life
- •Liver failure (AST or ALT levels with three times the upper limit of the range of normal values or higher)
- •Proven congenital or intrauterine fungal infection
研究组 & 干预措施
Population PK
Experimental
干预措施: Fluconazole (Drug)
结局指标
主要结局
drug level of fluconazole
时间窗: 30min later, 10-12hr later, at routine lab with interval of 1week
four times drug level after 3th dose
次要结局
未报告次要终点
研究者
Han-Suk Kim
Professor
Seoul National University Hospital
研究点 (1)
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