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

Completed

• Conditions: Infections, Rotavirus
• Interventions: Other: Stool sample; Other: Data collection

• Registration Number: NCT01733849
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Study Timeline

• Study First Submitted: 2012-11-21
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-27
• Study Start: 2012-12
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-16
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1266

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group Bulgaria	Stool sample	Subjects in this group include infants/children from Bulgaria, less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE.
Group Bulgaria	Data collection	Subjects in this group include infants/children from Bulgaria, less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE.
Group Latvia	Data collection	Subjects in this group include infants/children from Latvia, less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE.
Group Latvia	Stool sample	Subjects in this group include infants/children from Latvia, less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE.

Primary Outcome Measures

Name	Time	Method
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.	At the time of enrollment of each subject (Day 0).

Secondary Outcome Measures

Name	Time	Method
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.	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.	At the time of enrollment of each subject (Day 0).
Number of hospitalisations for RV GE and AGE, reported at the primary care settings.	At the time of phone call follow-up contact (14 to 19 days after enrollment).

Trial Locations

Locations (1)

GSK Investigational Site; 🇱🇻 Ventspils, Latvia