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

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

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.

Study Overview

• Status: Unknown
• Conditions: Rotavirus Infection

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 Type: Observational
• Enrollment (Actual): 2260

Contacts and Locations

Study Locations

• Estonia
  • Tartu, Estonia, 50411
    • Department of Microbiology, University of Tartu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All children less than 18-years-old hospitalized due to acute gastroenteritis to seven Estonian hospitals participating in this study from 02.2015-09.2016

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Hospitalized AGE patients; Children less than 18-years-old hospitalized due to acute gastroenteritis to seven Estonian hospitals participating in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The impact of rotavirus vaccination on hospitalizations due to acute gastroenteritis	Evaluate the impact of rotavirus vaccination on hospitalizations due to acute gastroenteritis	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The severity of disease according to Vesikari and Clark severity scales	Measure the severity of disease according to Vesikari and Clark severity scales	up to 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prevalence of rotavirus, adenovirus, astrovirus, norovirus G1, G2 and sapovirus gastroenteritis in Estonia after the implementation of rotavirus vaccine	Determine the prevalence of rotavirus, adenovirus, astrovirus, norovirus G1, G2 and sapovirus gastroenteritis in Estonia after the implementation of rotavirus vaccine	up to 2 years
Rotavirus genotypes	Determine the genotypes of circulating rotavirus	up to 2 years
Intussusception	Monitor the incidence of intussusception during the study period	up to 2 years

Collaborators and Investigators

• Sponsor: University of Tartu
• Investigators: Study Chair: Irja Lutsar, PhD, Institute of Microbiology, University of Tartu

Publications and helpful links

General Publications

• Koivumagi K, Soeorg H, Toompere K, Kallas E, Joegeda EL, Lass E, Huik K, Lutsar I; RV Study group. Rotavirus Strain Surveillance in Estonia After Introduction of Rotavirus Universal Mass Vaccination. Pediatr Infect Dis J. 2021 May 1;40(5):489-494. doi: 10.1097/INF.0000000000003039.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: January 14, 2016
• First Submitted That Met QC Criteria: January 20, 2016
• First Posted (Estimate): January 25, 2016

Study Record Updates

• Last Update Posted (Estimate): December 21, 2016
• Last Update Submitted That Met QC Criteria: December 20, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: vaccination; acute gastroenteritis; impact; rotavirus,; Estonia; severity scales
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Gastrointestinal Diseases; Reoviridae Infections; Gastroenteritis; Rotavirus Infections
• Other Study ID Numbers: 224/T-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO