Hospital-based Surveillance to Estimate the Disease Burden of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 1,234
- Locations
- 1
- Primary Endpoint
- Incidence of medical care associated rotavirus gastroenteritis among all hospitalised children < 5 years of age
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Incidence of medical care associated rotavirus gastroenteritis among all hospitalised children < 5 years of age
Time Frame: At least 12 months from study start
Proportion of rotavirus gastroenteritis among all acute gastroenteritis hospitalisations of children < 5 years of age
Time Frame: At least 12 months from study start
Proportion of rotavirus gastroenteritis among all acute gastroenteritis emergency room visits for children < 5 years of age
Time Frame: At least 12 months from study start
Secondary Outcomes
- 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)