NL-OMON39472已完成2 期
Pharmacokinetics and safety of Meropenem in infants below 90 days of age (inclusive) with probable and confirmed meningitis: a European multicenter phase I- II trial - Neomero 2
PENTA Foundation / Dept. of Pediatrics0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
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.
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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