EUCTR2010-020204-30-GB进行中（未招募）1 期
A Multicenter, Open-label, Sequential, Multiple-dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Efficacy or Eritoran in Descending Age Groups of Pediatric Subjects with Severe Sepsis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Male and female subjects, age from gestational age greater than or equal to 38 weeks to less than 18 years with confirmed early-onset sepsis, as defined in the protocol
- •- Must be a reasonable likelihood that the study drug adminstration can begin within 24 hours of the onset of sepsis-induced cardiovascular or respiratory organ dysfunction, whichever occurs first
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Subjects with either sepsis-induced cardiovascular or respiratory organ dysfunction for greater than 24 hours before likely start time of study drug administration
- •- Subjects who experienced an episode of sepsis-induced organ dysfunction (cardiovascular or respiratory) within the prior 45 days
- •- Subjects whose death appears imminent
研究者
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