Status:
COMPLETED
Surveillance Study to Estimate the Proportion of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
Up to 5 years
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. * Su...
Eligibility Criteria
Inclusion
- 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
- Not applicable
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
1234 Patients enrolled
Trial Details
Trial ID
NCT01253967
Start Date
February 1 2008
End Date
January 1 2010
Last Update
April 13 2015
Active Locations (8)
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1
GSK Investigational Site
Bucharest, Romania, 021105
2
GSK Investigational Site
Bucharest, Romania
3
GSK Investigational Site
Cluj-Napoca, Romania, 400348
4
GSK Investigational Site
Cluj-Napoca, Romania