NCT01851954终止2 期
Pharmacokinetic Study of Clarithromycin in Premature Infants With Safety Evaluation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- pharmacokinetics
研究概览
简要总结
The purpose of this study is to investigate the pharmacokinetics of clarithromycin which is used for premature infants with ureaplasma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •birthweight < 1500gm or GA < 32 weeks
- •transtracheal aspirate/gastric juice ; ureaplasma/mycoplasma(+)
排除标准
- •sepsis, hypotension, shock
- •major congenital anomaly
研究组 & 干预措施
clarithromycin
Experimental
Population PK
干预措施: Clarithromycin (Drug)
结局指标
主要结局
pharmacokinetics
时间窗: 72 hours after first infusion
AUC, Cmax
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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