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

Rotavirus Infection Clinical Trial

— ERVS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02662543
• Other study ID #: 224/T-3
• Status: Active, not recruiting
• Phase: N/A
• First received: January 14, 2016
• Last updated: December 20, 2016
• Start date: February 2015
• Est. completion date: August 2020

Study information

• Verified date: December 2016
• Source: University of Tartu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Estonia: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2260
• Est. completion date: August 2020
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroenteritis
• Rotavirus Infection
• Rotavirus Infections

Locations

Country	Name	City	State
Estonia	Department of Microbiology, University of Tartu	Tartu

Sponsors (1)

Lead Sponsor	Collaborator
University of Tartu

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Rotavirus genotypes	Determine the genotypes of circulating rotavirus	up to 2 years	No
Other	Intussusception	Monitor the incidence of intussusception during the study period	up to 2 years	No
Primary	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	No
Secondary	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	No