Clinical Trial: The Epidemiology and Etiology of Acute Gastroenteritis Among Estonian Children After Introduction of Rotavirus Vaccines

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: University of Tartu

Current Primary Outcome: The impact of rotavirus vaccination on hospitalizations due to acute gastroenteritis [ Time Frame: up to 2 years ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome: The severity of disease according to Vesikari and Clark severity scales [ Time Frame: up to 2 years ]

Measure the severity of disease according to Vesikari and Clark severity scales


Original Secondary Outcome: Same as current

Information By: University of Tartu

Dates:
Date Received: January 14, 2016
Date Started: February 2015
Date Completion: August 2020
Last Updated: December 20, 2016
Last Verified: December 2016