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临床试验/NCT00895492
NCT00895492已完成不适用

Two Year (2009-2010) Surveillance of Rotavirus Genotypes Causing Acute Diarrhea in Children Younger Than 5 Years of Age Requiring Emergency Room and Hospital Admission in Two Large Cities in Chile.

University of Chile2 个研究点 分布在 1 个国家目标入组 967 人开始时间: 2009年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
967
试验地点
2
主要终点
Proportion of rotavirus VP7 and VP4 genotypes

研究概览

简要总结

The purpose of this study is to prospectively determine the rotavirus VP7/VP4 genotypes associated with moderate to severe disease (requiring emergency room (ER) consult or hospitalization) in a large public hospital from Valparaiso and another from Santiago.

详细描述

Rotavirus is the leading cause of gastroenteritis in children. Our group has developed a surveillance system for acute rotavirus diarrhea in two large hospitals in Chile since 2006. Patients visiting the ER for acute non-bloody diarrhea will be enrolled after an informed consent is signed by parents. A fresh stool sample will be collected to prospectively determine the rotavirus VP7/VP4 genotypes associated with moderate to severe disease (requiring emergency room (ER) consult or hospitalization. Stool samples will be tested for rotavirus by ELISA IDEIA - Rotavirus - OXOID. Rotavirus positive samples will be genotyped as described previously (Iturriza-Gomara et al. J. Clinical Virol 2004). Overall medical visits and hospitalizations, proportion of visits and hospitalizations caused by acute diarrhea, estimated numbers of rotavirus visits and hospitalizations will be calculated for each site. Proportion of rotavirus VP7 and VP4 genotypes will be calculated for three month periods per center. Differences in proportion will be compared by chi square and Fischer's exact test when appropriate.

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
1 Month 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with acute diarrhea
  • Children younger than 5 years

排除标准

  • Illiterate parents
  • Chronic gastrointestinal disease

结局指标

主要结局

Proportion of rotavirus VP7 and VP4 genotypes

时间窗: two years

次要结局

  • Proportion of rotavirus positive episodes(two years)

研究者

发起方
University of Chile
申办方类型
Other
责任方
Principal Investigator
主要研究者

Miguel O'Ryan Gallardo

Full Professor, Microbiology and Mycology Department of Medicine Faculty, Universidad de Chile.

University of Chile

研究点 (2)

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