A Study to Estimate the Occurrence of Rotavirus Gastroenteritis in Children < 5 Years of Age, in Bulgaria and Latvia

GlaxoSmithKline1,266 enrolled

Overview

This study aims to estimate the real situation of rotavirus gastroenteritis (RV GE) in the primary care settings of both Bulgaria and Latvia in children less than 5 years of age.

A Primary care setting will include independent general practitioners (GP) (specialised in paediatrics) or independent paediatricians. Stool samples will be collected from all enrolled subjects at Visit 1 (Day 0) and tested immediately after collection. The stool sample will be stored for 24 hours only, in case the test cannot be performed immediately after collection.

Study Type

OBSERVATIONAL

Enrollment

1,266

Conditions

Infections, Rotavirus

Interventions

Stool sampleOTHER

Samples will be tested to determine the presence or absence of rotavirus.

Data collectionOTHER

Log books

Eligibility

Sex: ALLMax age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Infants/children with home visits by the GPGP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for AGE treatment during the study period. * A male or female infant/child less than five years of age at the time of the GP/paediatrician visit. A child becomes ineligible on the day of her/his fifth birthday. * Written informed consent obtained from the parents/legally acceptable representative (LARs) of the subject. * Subjects who the investigator believes that his/her, parents/LARs can and will comply with the requirements of the protocol. Exclusion Criteria: • Child in care.

Locations (57)

Outcomes

Primary Outcomes

Number of RV GE cases among the acute gastroenteritis (AGE) cases reported at primary care settings in infants/children less than five years of age.

Time frame: At the time of enrollment of each subject (Day 0).

Secondary Outcomes

Symptoms related to AGE and their measures, stratified by rotavirus status for all the AGE cases reported by infants/children less than five years of age at the primary care settings.

Time frame: Day 0 - Day 14+5 (At the time of phone call follow-up contact).

Number of RV GE cases reported at each month by infants/children less than five years of age reported at the primary care settings.

Time frame: At the time of enrollment of each subject (Day 0).

Number of hospitalisations for RV GE and AGE, reported at the primary care settings.

Time frame: At the time of phone call follow-up contact (14 to 19 days after enrollment).

Data from ClinicalTrials.gov

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GSK Investigational Site

Burgas, Bulgaria

GSK Investigational Site

Burgas, Bulgaria

GSK Investigational Site

Dobrich, Bulgaria

GSK Investigational Site

Pazardzhik, Bulgaria

GSK Investigational Site

Pleven, Bulgaria

GSK Investigational Site

Plovdiv, Bulgaria

GSK Investigational Site

Rousse, Bulgaria

GSK Investigational Site

Sliven, Bulgaria

GSK Investigational Site

Sofia, Bulgaria

GSK Investigational Site

Sofia, Bulgaria

...and 47 more locations