EUCTR2011-001515-31-LT进行中（未招募）不适用
Efficacy, pharmacokinetics and safety of Meropenem in infants below 90 days of age (inclusive) with clinical or confirmed late-onset sepsis: an European multicenter randomised phase III trial - Meropenem fot the treatment of late onset neonatal sepsis
PENTA Foundation Onlus0 个研究点目标入组 550 人开始时间: 2011年12月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 550
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
- 性别
- All
入选标准
- •Informed consent form signed by the parents/carers
- •? Chronological age below 90 days inclusive
- •? Chronological age greater or equal to 72 hours of life at beginning of LOS
- •? Clinical or confirmed sepsis
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 550
- •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
- •Administration of any systemic antibiotic regimen for more than 24 hours
- •prior to the administration of the study drug, unless the change is driven
- •by the lack of efficacy of the former regimen;
- •? Severe congenital malformations if the infant is not expected to survive
- •for more than 3 months;
- •? Other situations where the treating physician considers a different
- •antibiotic regimen necessary;
- •? Known intolerance or contraindication to study medication;
- •? Participation in any other clinical study of investigational drugs;
- •? Renal failure (as defined by Akcan-Arikan et al., 2007) and requirement
- •for haemofiltration or peritoneal dialysis;
- •? Confirmed sepsis with microorganisms known to be resistant to study
研究者
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