EUCTR2011-001521-25-GR进行中（未招募）不适用
Pharmacokinetics and safety of meropenem in infants below 90 days ofage (inclusive) with probable and confirmed meningitis: a Europeanmulticentre phase I-II trial
PENTA Foundation (Fondazione Penta Onlus)0 个研究点目标入组 60 人开始时间: 2011年12月7日最近更新:
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
- 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
- •- 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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