Clinical trial NCT02662543: The Epidemiology and Etiology of Acute Gastroenteritis Among Estonian Children After Introduction of Rotavirus Vaccines
Official title: The Epidemiology and Etiology of Acute Gastroenteritis Among Estonian Children Aged < 18 Years After Introduction of Rotavirus Vaccines
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rotavirus Infection
Keywords: rotavirus,
acute gastroenteritis
vaccination
Estonia
impact
severity scales
Lead sponsor: University of Tartu
Sponsor class: OTHER
First posted: 2016-01-25
Enrollment: 2260
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The impact of rotavirus vaccination on hospitalizations due to acute gastroenteritis
timeFrame: up to 2 years
Secondary outcomes:
measure: The severity of disease according to Vesikari and Clark severity scales
timeFrame: up to 2 years
Other outcomes:
measure: The prevalence of rotavirus, adenovirus, astrovirus, norovirus G1, G2 and sapovirus gastroenteritis in Estonia after the implementation of rotavirus vaccine
timeFrame: up to 2 years
measure: Rotavirus genotypes
timeFrame: up to 2 years
measure: Intussusception
timeFrame: up to 2 years
Locations:
city: Tartu
country: Estonia
facility: Department of Microbiology, University of Tartu
Study officials:
affiliation: Institute of Microbiology, University of Tartu
name: Irja Lutsar, PhD
role: STUDY_CHAIR
References:
citation: 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.