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临床试验/NCT03550937
NCT03550937已完成不适用

Hospital-based Surveillance of Severe Rotavirus Gastroenteritis and Diversity of Circulating Rotavirus Strains in Young Taiwanese Children

National Taiwan University Hospital10 个研究点 分布在 1 个国家目标入组 5,040 人开始时间: 2013年12月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,040
试验地点
10
主要终点
monitor the strain diversity of rotavirus in Taiwan

研究概览

简要总结

Rotavirus remains among the leading causes of pediatric gastroenteritis requiring hospitalization in the world. Surveillance studies revealed that more than 90% of the global circulating rotavirus strains were predominated by several major genotypes. Clinical trials and post-marketing studies have demonstrated that the currently available rotavirus vaccine can provide sufficient protection against strains of the prevalent genotypes. However, the emerging strains with new genotypes were increasingly reported in the past decade, an ongoing surveillance of the strain changes is needed in the regions where the pediatric population is either fully or partly immunized. In this project, the investigators will setup a hospital-based gastroenteritis surveillance network by incorporating 8 major hospitals in northern, central, southern and eastern Taiwan. From 2013 to 2015, children aged 5 years or younger hospitalized to one of the 8 sentinel hospitals due to acute gastroenteritis will be screened for rotavirus infection, and viral proteins 7 [VP7] (G type) and viral proteins 4 [VP4] (P type) genotypes of rotavirus will be determined for each infected case. The demographics and clinical manifestations of study subjects will also be collected and analyzed. Through this project, the investigators will be able to detect emerging genotypes of rotavirus and delineate the strain distribution during the two years of study in Taiwan. The investigators can also have more comprehensive understanding of the epidemiology of rotavirus regarding to the incidence, disease characteristics, temporal and geographic variations of severe rotavirus gastroenteritis in Taiwanese children. Results from this project will provide valuable information for future implementation of mass immunization against rotavirus in Taiwan.

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

  • aged less than 60 months,
  • hospitalized in 1 of the 8 hospitals,
  • having diarrhea not caused by any known underlying diseases.

排除标准

  • 未提供

结局指标

主要结局

monitor the strain diversity of rotavirus in Taiwan

时间窗: 4 years

monitor the strain diversity of rotavirus in Taiwan, including the individual serotype prevalence and emerging genotypes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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