EUCTR2011-001515-31-GR进行中（未招募）不适用
EFFICACY, PHARMACOKINETICS AND SAFETY OF MEROPENEM ININFANTS BELOW 90 DAYS OF AGE (INCLUSIVE) WITH CLINICAL ORCONFIRMED LATE-ONSET SEPSIS: A EUROPEAN MULTICENTERRANDOMISED PHASE III TRIAL - meropenem for 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7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
- •- 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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