National Observatory of Bacterial Meningitis in Children and Newborns
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- mortality
研究概览
简要总结
Bacterial meningitis is a major cause of morbidity and mortality in childhood. Antibiotic treatment recommendations are based on epidemiological and susceptibility data. The epidemiology of bacterialméningitis has changed in recent years, mainly owing to widespread use of different conjugate vaccines. The aim of this prospective national survey is to describe epidemiology of bacteria implicated in bacterial meningitis in children.
详细描述
For children under 18, hospitalized for bacterial meningitis, the following data will be analyzed: risk factors, vaccination status, signs of symptoms, treatment during hospitalization, analysis (cerebrospinal fluid culture, cerebrospinal fluid antigen test, blood culture...), symptoms or clinic signs of illness.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical signs of meningitis, associated with positive cerebrospinal fluid (CSF) culture and/or positive CSF antigen testing (Escherichia coli K1, N. meningitidis serogroups B, A, C, Y and W-135, group B streptococci, Hib, or S. pneumoniae), and/or positive CSF polymerase chain reaction (PCR), and/or positive blood culture with CSF pleocytosis (> 10 cells/µL).
- •purpura fulminans
排除标准
- 未提供
结局指标
主要结局
mortality
时间窗: before the hospital discharge
Number of death according to age and bacteria
次要结局
- treatment failures(48 hours after the antibiotic treatment and new lumbar puncture)
- impact of vaccines(before the hospital discharge)