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

January 27, 2011 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

642

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children < 5 years of age in Sweden

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Children hospitalised with community-acquired severe RV GE and children acquiring nosocomial severe RV GE.
Procedure: Blood sample collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To estimate the incidence of severe rotavirus gastroenteritis (RV GE) and its associated complications in children < 5 years of age.

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

June 20, 2007

First Submitted That Met QC Criteria

June 20, 2007

First Posted (Estimate)

June 21, 2007

Study Record Updates

Last Update Posted (Estimate)

January 31, 2011

Last Update Submitted That Met QC Criteria

January 27, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109551

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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