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临床试验/NCT01201252
NCT01201252已完成不适用

An Observational, Hospital-based Surveillance to Estimate the Disease Burden of Acute Rotavirus (RV) Gastroenteritis (GE) in Children < 5 Years of Age in United Arab Emirates (UAE).

GlaxoSmithKline1 个研究点 分布在 1 个国家目标入组 717 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
717
试验地点
1
主要终点
Occurrence of diarrhoeal hospitalisations in children < 5 years of age, which are attributable to rotavirus.

研究概览

简要总结

The purpose of this study is to estimate the disease burden and epidemiology of rotavirus gastroenteritis in children less than 5 years of age, in United Arab Emirates. Acute gastroenteritis cases will be identified from acute gastroenteritis hospitalisation log book and stool samples will be collected from all suspected and confirmed acute gastroenteritis cases.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • A male or female < 5 years of age at the time of admission to the study hospital for acute gastroenteritis.
  • Written informed consent obtained from the parent or guardian of the subject.

排除标准

  • The diagnosis for treatment at the study site does not include acute gastroenteritis.
  • The onset of acute gastroenteritis after admission to the hospital i.e. 48 hours after hospital admission.

结局指标

主要结局

Occurrence of diarrhoeal hospitalisations in children < 5 years of age, which are attributable to rotavirus.

时间窗: Twelve months from study initiation

次要结局

  • Distribution of different strains of rotavirus in children < 5 years of age.(Twelve months from study initiation)
  • Age and seasonal distribution of hospitalisations associated with rotavirus in children < 5 years of age.(Twelve months from study initiation)
  • Occurrence of severe dehydrating rotavirus gastroenteritis based on Vesikari scale among children < 5 years of age.(Twelve months from study initiation)
  • Occurrence of intravenous re-hydration treatment and/or other treatments due to rotavirus gastroenteritis.(Twelve months from study initiation)
  • Occurrence of acute gastroenteritis and rotavirus gastroenteritis among all hospitalisations of children < 5 years of age.(Twelve months from study initiation)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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