NCT02662543

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

December 21, 2016

Status Verified

December 1, 2016

Enrollment Period

3.5 years

First QC Date

January 14, 2016

Last Update Submit

December 20, 2016

Conditions

Rotavirus Infection

Keywords

rotavirus,acute gastroenteritisvaccinationEstoniaimpactseverity scales

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The severity of disease according to Vesikari and Clark severity scales

    up to 2 years

Other Outcomes (3)

  • 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

    up to 2 years

  • Intussusception

    up to 2 years

Study Arms (1)

Hospitalized AGE patients

Children less than 18-years-old hospitalized due to acute gastroenteritis to seven Estonian hospitals participating in this study

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Microbiology, University of Tartu

Tartu, 50411, Estonia

Location

Related Publications (1)

  • 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.

    PMID: 33847298DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples

MeSH Terms

Conditions

Rotavirus InfectionsTooth, Impacted

Condition Hierarchy (Ancestors)

Reoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsTooth DiseasesStomatognathic Diseases

Study Officials

  • Irja Lutsar, PhD

    Institute of Microbiology, University of Tartu

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 25, 2016

Study Start

February 1, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2020

Last Updated

December 21, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)