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临床试验/NCT02662543
NCT02662543Unknown不适用

The Epidemiology and Etiology of Acute Gastroenteritis Among Estonian Children Aged < 18 Years After Introduction of Rotavirus Vaccines

University of Tartu1 个研究点 分布在 1 个国家目标入组 2,260 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,260
试验地点
1
主要终点
The impact of rotavirus vaccination on hospitalizations due to acute gastroenteritis

研究概览

简要总结

This study is designed to estimate the changes in the etiology and epidemiology of acute gastroenteritis in children aged less than 18 years after the implementation of rotavirus vaccine in the Estonian national immunization program in July 2014.

详细描述

The two-year study period started in February 2015.

The study population consists of all children less than 18-years-old hospitalized due to acute gastroenteritis (AGE) to seven Estonian hospitals participating in this study. Expected sample size is about 2000 patients.

Hospitals that participate in this study are Tartu University Hospital, West-Tallinn Central Hospital, Tallinn's Children Hospital, Pärnu Central Hospital, South-Estonian Hospital, Kuressaare Hospital and Ida-Viru Central Hospital.

Before enrollment all patients are asked to give an informed consent. After enrollment the study doctor completes electronic questionnaire regarding the patients demographic data, medical history and vaccinations. Specific database for our study has been created by company Vision 5D. After completing electronic questionnaire the doctor collects 2 stool samples each 2 ml of volume into Eppendorf tubes produced by our study laboratory. The samples are transported to our study laboratory where they are tested for rotavirus, norovirus G1, G2, astrovirus, adenovirus and sapovirus with Fast-Track Diagnostics real-time assay kit FTD Viral Gastroenteritis. The samples positive for rotavirus are refrigerated at -70 degrees for further genotyping and sequencing.

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • children aged < 18 year
  • hospitalized due to acute gastroenteritis

排除标准

  • children aged > 18 years
  • gastroenteritis due to known non-infectious causes

结局指标

主要结局

The impact of rotavirus vaccination on hospitalizations due to acute gastroenteritis

时间窗: up to 2 years

Evaluate the impact of rotavirus vaccination on hospitalizations due to acute gastroenteritis

次要结局

  • The severity of disease according to Vesikari and Clark severity scales(up to 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kadri Kõivumägi

PhD student

University of Tartu

研究点 (1)

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