EUCTR2011-001521-25-EE进行中（未招募）不适用
Pharmacokinetics and safety of Meropenem in infants below 90 days of age (inclusive) with probable and confirmed meningitis: a European multicenter phase II trial - Neomero2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
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 • The presence of: clinical signs consistent with bacterial meningitis (clinical signs of meningitis are: fever or hypothermia or temperature instability PLUS 1 or more neurological findings e.g. coma, seizures, neck stiffness, apnoea, bulging fontanelle) OR CSF pleocytosis (= 20 cells / mm3 OR a positive Gram stain of CSF).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •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
- •Presence of a CSF device • Proven viral or fungal meningitis • Severe congenital malformations if the infant is not to expect to survive for more than 3 months • Other situations where the treating physician considers a different empiric antibiotic regimen necessary • Known intolerance or contraindication to the study medication • Participation in any other clinical study of an investigational medicinal product • Renal failure and requirement of haemofiltration or peritoneal dialysis • Meningitis with an organism known to be resistant to meropenem
研究者
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