NCT02862847已完成不适用
Study of the Prevalence of Cosavirus and Salivirus Infections, Two New Genera of Picornaviridae, In Infants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 615
- 试验地点
- 1
- 主要终点
- Rate of viruses detected
研究概览
简要总结
Cosavirus and Salivirus are two new genera of Picornaviridae and are responsible for acute diarrhoea. They have been identified in the pathological stools of infants and immuno-compromised subjects on every continent with prevalences ranging from 2.8% to 8.8% depending on the virus, the cohort and the country studied.
To date, no study on these two viruses has been conducted in France to evaluate the circulation and the pathogenicity of these viruses in subjects with diarrhoea.
The aim of this study is thus to:
- show that these viruses are in circulation in France in infants younger than 5 years old and that the proportions are similar to those reported in the literature.
- confirm the relationship between the diarrhoea and the infection with these viruses.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children younger than 5 years
- •Children hospitalized or consulting at Dijon CHU during the 12 months of the study for acute gastroenteritis. Acute gastroenteritis is defined by at least 3 soft or liquid stools or at least 3 bouts of vomiting within 24 hours or signs (diarrhoea or vomiting) accompanied by at least 2 additional symptoms among diarrhoea or vomiting, abdominal pain, fever
- •for controls
- •Children younger than 5 years old
- •Children hospitalized or consulting at Dijon CHU during the 12 months of the study for any illness without diarrhoea (other than exclusion criteria).
排除标准
- •Persons without national health insurance cover
- •Children older than 5 years.
- •Children presenting chronic diarrhoea (> 2 weeks) (e.g. Crohn and UC)
- •Children with immune deficiency.
- •Children with nosocomial gastroenteritis; the nosocomial aspect will be defined as the onset of acute diarrhoea occurring after the 48th hour after admission
- •for controls
- •Persons without national health insurance cover
- •Children older than 5 years.
- •Children with chronic diarrhoea (> 2 weeks) (e.g. Crohn and UC)
- •Children with immune deficiency.
结局指标
主要结局
Rate of viruses detected
时间窗: Baseline
次要结局
未报告次要终点
研究者
研究点 (1)
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