Infections, Rotavirus
Conditions
Keywords
Gastroenteritis, Hospital surveillance, Rotavirus gastroenteritis
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
Interventions
PROCEDURECollection of stool samples
Stool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped.
OTHERHealth economics questionnaire
For a subset of subjects, additional economic data will be gathered by completing a questionnaire
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Incidence of medical care associated rotavirus gastroenteritis among all hospitalised children < 5 years of age | At least 12 months from study start |
Secondary
| Measure | Time frame |
|---|---|
| Rotavirus gastroenteritis associated costs | 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 |
| 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 |
| Percentage of rotavirus genotypes amongst all isolated strains in 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 |
Countries
Romania
Outcome results
None listed