Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT01253967
Status:
COMPLETED
Last Update Posted:
2015-04-13
First Post:
2010-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surveillance Study to Estimate the Proportion of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Hospital-based Surveillance to Estimate the Disease Burden of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: