EUCTR2011-001521-25-NL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-II trial - NEOMERO2
PENTA Foundation (Fondazione Penta Onlus)0 个研究点目标入组 60 人开始时间: 2012年2月1日最近更新:
适应症
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: 8
- •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
相似试验
进行中（未招募）
不适用
How well does meropenem treat meningitis in infants below and including 90 days of ageEUCTR2011-001521-25-GBFONDAZIONE PENTA60
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 trialEUCTR2011-001521-25-GRPENTA Foundation (Fondazione Penta Onlus)60
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 trialbacterial meningitisinfection of the central nervous system1000401810007951NL-OMON39472PENTA Foundation / Dept. of Pediatrics10
进行中（未招募）
不适用
Meropenem for the treatment of serious bacterial infections in neonates and young infantsproven or suspected bacterial meningitis in neonates and infants up to90 days of ageMedDRA version: 14.1Level: PTClassification code 10058780Term: Meningitis neonatalSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-001521-25-LTPENTA Foundation Onlus60
进行中（未招募）
不适用
Meropenem in meningitis in children up to 90 days of ageBacterial meningitis in children up to 90 days of ageMedDRA version: 17.0Level: LLTClassification code 10004049Term: Bacterial meningitisSystem Organ Class: 100000004862EUCTR2011-001521-25-EEFONDAZIONE PENTA ONLUS60