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

• Conditions: Rotavirus Infection

• Registration Number: NCT02662543
• Lead Sponsor: University of Tartu

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 Description

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2016-01-14
• Study First Submitted QC: 2016-01-20
• Study First Posted: 2016-01-25
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-20
• Last Update Posted: 2016-12-21
• Primary Completion: 2018-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2260

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The impact of rotavirus vaccination on hospitalizations due to acute gastroenteritis	up to 2 years	Evaluate the impact of rotavirus vaccination on hospitalizations due to acute gastroenteritis

Secondary Outcome Measures

Name	Time	Method
The severity of disease according to Vesikari and Clark severity scales	up to 2 years	Measure the severity of disease according to Vesikari and Clark severity scales

Trial Locations

Locations (1)

Department of Microbiology, University of Tartu; 🇪🇪 Tartu, Estonia