EUCTR2011-001515-31-EE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 - Neomero 1
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 antibiotics for more than 24 hours prior to the randomisation, 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 of haemofiltration or peritoneal dialysis; • Confirmed sepsis with microorganisms known to be resistant to study therapies.
研究者
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