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临床试验/NCT04664556
NCT04664556招募中不适用

Population-based Nationwide Study on Invasive Pneumococcal Infections Among Children (0-18 Years) in France

Association Clinique Thérapeutique Infantile du val de Marne2 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2010年12月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,500
试验地点
2
主要终点
Severity of invasive pneumococcal disease

研究概览

简要总结

After 7 then 13 valent pneumococcal conjugate vaccine (PCV) implementation in France in children, we will evaluate the impact of this vaccination on invasive pneumococcal disease (IPD). We will describe the clinical characteristics of IPD, pneumococcus serotyping, underlying conditions and vaccination status.

详细描述

For children under 18, hospitalized for IPD, the following data will be analyzed: risk factors, vaccination status, severity signs , treatment during hospitalization, biological analysis, the clinical location of the disease.

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

入选标准

  • Isolate of Streptococcus pneumoniae from at least one blood culture, or pleural fluid, or joint fluid, or cerebrospinal fluid or other normally sterile body site, or if there is a positive blood polymerase chain reaction (PCR).

排除标准

  • Pneumococcal strain not transmetted to National Reference Center for Pneumococci or to Regional Pneumococci Observatory

结局指标

主要结局

Severity of invasive pneumococcal disease

时间窗: before hospital discharge

Number of severe cases according to age and pneumococcal serotypes distribution

次要结局

  • Impact of vaccines(before hospital discharge)

研究者

发起方
Association Clinique Thérapeutique Infantile du val de Marne
申办方类型
Other
责任方
Sponsor

研究点 (2)

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