NCT01733849

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

An Observational Study to Estimate the Disease Burden of Rotavirus Gastroenteritis in Infants/Children Less Than Five Years of Age in Primary Care Settings, in Bulgaria and Latvia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,266 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Infections, Rotavirus

Interventions

Type	Name	Description
OTHER	Stool sample	Samples will be tested to determine the presence or absence of rotavirus.
OTHER	Data collection	Log books

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2012-11-27
• Last updated: 2017-01-18

Locations

57 sites across 2 countries: Bulgaria, Latvia