Hospital-based Surveillance to Collect Prospective Data to Estimate the Disease Burden of Severe RV GE in Sweden

Infections, Rotavirus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489567
• Other study ID #: 109551
• Status: Completed
• Phase: N/A
• First received: June 20, 2007
• Last updated: January 27, 2011
• Start date: October 2007
• Est. completion date: October 2008

Study information

• Verified date: January 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

This study aims to estimate the burden of RV GE. The study will focus on children hospitalized for severe RV GE, Children acquiring RV GE in the hospital and the household contacts of children hospitalized with RV GE. It is expected to enrol 500-600 subjects in the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 642
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

Inclusion Criteria:

• Written informed consent obtained from parent or guardian

• A male/ female child aged less than 5 years. On the day of fifth birthday the subject is not eligible for participation

• Hospitalised for acute GE

• Developed symptoms of acute GE 72 hours after hospitalisation

• Stool sample should be positive for the presence of rotavirus, which will be detected either by Vikia test or by ELISA

Inclusion criteria for household members:

• Family members including care-takers and sibling staying in the same house and who spend most of the nights (50%) with the sick child.

• Written permission from care-takers or siblings or their parents.

Exclusion Criteria:

• All children in the neonatal wards.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroenteritis
• Infections, Rotavirus
• Rotavirus Gastroenteritis
• Rotavirus Infections

Intervention

Procedure:
• Blood sample collection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the incidence of severe rotavirus gastroenteritis (RV GE) and its associated complications in children < 5 years of age.			No
Secondary	To determine the gender, age of onset, severity of symptoms and underlying medical conditions in community and nosocomially acquired rotavirus infections			No
Secondary	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.			No
Secondary	To estimate the incidence of liver involvement associated with RV GE and relate this to clinical symptoms in the population under surveillance.			No
Secondary	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.			No
Secondary	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			No