Hospital-based Surveillance to Collect Prospective Data to Estimate the Disease Burden of Severe RV GE in Sweden
|ClinicalTrials.gov Identifier: NCT00489567|
Recruitment Status : Completed
First Posted : June 21, 2007
Last Update Posted : January 31, 2011
|Condition or disease||Intervention/treatment|
|Rotavirus Gastroenteritis Infections, Rotavirus||Procedure: Blood sample collection|
|Study Type :||Observational|
|Actual Enrollment :||642 participants|
|Official Title:||A Hospital-based Surveillance to Collect Prospective Data to Estimate the Disease Burden of Severe RV GE, Its Complications and Diversity of Co-circulating Rotavirus Strains in Children < 5 Years of Age in Sweden|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
Children hospitalised with community-acquired severe RV GE and children acquiring nosocomial severe RV GE.
|Procedure: Blood sample collection|
- To estimate the incidence of severe rotavirus gastroenteritis (RV GE) and its associated complications in children < 5 years of age.
- To determine the gender, age of onset, severity of symptoms and underlying medical conditions in community and nosocomially acquired rotavirus infections
- To check the incidence of RV antigenemia and viremia associated with severe RV GE and relate this to clinical symptoms and rate of complications in population under surveillance.
- To estimate the incidence of liver involvement associated with RV GE and relate this to clinical symptoms in the population under surveillance.
- To explore the possible role of anti-secretory factor in children with RV GE and relate this to clinical symptoms and rate of complications under surveillance.
- To genotype the isolated rotavirus strains and evaluate a possible correlation to evolved antigenemia, liver involvement and complications in both nosocomially and community-acquired cases with infection of different strain
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489567
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|