NCT01730391已完成不适用
Neisseria Meningitidis Burden of Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 521
- 试验地点
- 1
- 主要终点
- Serogroup of N. meningitis positive samples
研究概览
简要总结
This study aims to provide an estimate of the proportion of suspected cases of bacterial meningitis that are due to N. meningitidis and the serogroup responsible in The Philippines and Vietnam.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who the investigator believes can and will comply with the requirements of the protocol or subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the subject/from the parent(s)/LAR of the subject.
- •A male or female subject who visits the hospital with suspected bacterial meningitis.
- •CSF sample taken as part of routine practice.
排除标准
- •Child in care.
结局指标
主要结局
Serogroup of N. meningitis positive samples
时间窗: At enrollment (Day 0)
Prevalence of N. meningitis in CSF samples
时间窗: At enrollment (Day 0)
次要结局
- Prevalence of Haemophilus influenzae and Streptococcus pneumoniae in CSF samples as causes of bacterial meningitis(At enrollment (Day 0))
- Serotype of Streptococcus pneumoniae positive samples(At enrollment (Day 0))
- Further characterization of N. meningitidis using Multi Locus Sequence Typing(At enrollment (Day 0))
- Further classification of Haemophilus influenzae positive samples into Type B and non-B Types(At enrollment (Day 0))
- Total number of subjects with suspected bacterial meningitis (according to diagnostic criteria used by each participating hospital to identify this condition)(At enrollment (Day 0))
研究者
研究点 (1)
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