EUCTR2011-001515-31-ES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: A EUROPEAN MULTICENTER RANDOMISED PHASE III TRIAL.
PENTA Foundation Onlus0 个研究点目标入组 550 人开始时间: 2012年8月9日最近更新:
适应症
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
- •- Inform consent form signed by 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 regimn 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 in the infant is not expected to survive for more than 3 months;
- •- Other situations where the treating pysician 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 micororganisms known to be resistant to study therapies
研究者
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