EUCTR2011-001521-25-GB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 multicentre phase I-ll trial. - NEOMERO2
FONDAZIONE PENTA0 个研究点目标入组 60 人开始时间: 2012年3月21日最近更新:
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 (fever or hypothermia or temperature instability PLUS 1 or more neurological findings among coma, seizures, neck stiffness, apnoea, bulging fontanelle),
- •- OR CSF pleocytosis (= 20 cells/mm3)
- •- OR a positive Gram stain of CSF.
- •1. Where the initial results of the lumbar puncture do not support a diagnosis of meningitis e.g. where the cell count is < 20 cells/mm3, but the subsequent CSF culture (or PCR (see later)) is positive for a significant pathogen, then the infant will still be eligible for recruitment when these results become known.
- •2. Where the early lumbar puncture is deferred, for example, because the infant is clinically unstable, but the delayed lumbar puncture supports a diagnosis of meningitis (as above), then the infant will still be eligible for recruitment.
- •3. If the lumbar puncture is traumatic, the normal” ratio of 500 RBC: 1 WBC will be used to evaluate the CSF WCC result.
- •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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