Surveillance Study to Estimate the Proportion of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania

Completed

• Conditions: Infections, Rotavirus
• Interventions: Procedure: Collection of stool samples; Other: Health economics questionnaire

• Registration Number: NCT01253967
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this hospital based study is to estimate the proportion of rotavirus gastroenteritis in children \< 5 years of age in Romania.

Detailed Description

The study consist of a main study and a health economics study

Main study: The study will focus on three different groups of patients:

* Subjects who are hospitalised for acute gastroenteritis.

* Subjects who visit an emergency room for acute gastroenteritis.

* Subjects who have rotavirus positive laboratory results and developed acute gastroenteritis at least 48 hours after hospitalisation.

Health economics study: for a subset of subjects, additional economic data will be gathered by completing a questionnaire

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Study First Submitted: 2010-11-30
• Study First Submitted QC: 2010-12-02
• Study First Posted: 2010-12-06
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1234

Inclusion Criteria

• A male or female child aged < 5 years at the time of admission. A child becomes ineligible on the day of her/his fifth birthday.

• A subject, who during the study period:

  • Is hospitalised for acute gastroenteritis Or
  • Visits an emergency room for acute gastroenteritis Or
  • Has rotavirus positive laboratory results and develops acute gastroenteritis at least 48 hours after hospitalisation

Exclusion Criteria

Not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B	Health economics questionnaire	Subjects who visit an emergency room for acute gastroenteritis
Group A	Health economics questionnaire	Subjects who are hospitalised for acute gastroenteritis
Group B	Collection of stool samples	Subjects who visit an emergency room for acute gastroenteritis
Group C	Collection of stool samples	Subjects who have rotavirus positive laboratory results and developed acute gastroenteritis at least 48 hours after hospitalisation.
Group C	Health economics questionnaire	Subjects who have rotavirus positive laboratory results and developed acute gastroenteritis at least 48 hours after hospitalisation.
Group A	Collection of stool samples	Subjects who are hospitalised for acute gastroenteritis

Primary Outcome Measures

Name	Time	Method
Incidence of medical care associated rotavirus gastroenteritis among all hospitalised children < 5 years of age	At least 12 months from study start
Proportion of rotavirus gastroenteritis among all acute gastroenteritis hospitalisations of children < 5 years of age	At least 12 months from study start
Proportion of rotavirus gastroenteritis among all acute gastroenteritis emergency room visits for children < 5 years of age	At least 12 months from study start

Secondary Outcome Measures

Name	Time	Method
Age distribution of children with rotavirus gastroenteritis	At least 12 months from study start
Severity of rotavirus among all children < 5 years of age	At least 12 months from study
Proportion of rotavirus gastroenteritis among all hospitalisations of children < 5 years of age	At least 12 months from study start
Proportion of community acquired rotavirus gastroenteritis among all emergency room visits for children < 5 years of age	At least 12 months from study start
Seasonal distribution (if appropriate) of rotavirus among all children < 5 years of age	At least 12 months from study start
Potential risk factors for rotavirus gastroenteritis	At least 12 months from study start
Rotavirus gastroenteritis associated costs	At least 12 months from study start
Percentage of rotavirus genotypes amongst all isolated strains in children < 5 years of age	At least 12 months from study start
Proportion of acute gastroenteritis among all hospitalisations of children < 5 years of age	At least 12 months from study start
Proportion of community acquired acute gastroenteritis among all emergency room visits for children < 5 years of age	At least 12 months from study start

Trial Locations

Locations (1)

GSK Investigational Site; 🇷🇴 Timisoara, Romania