Text Size

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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00489567
First received: June 20, 2007
Last updated: January 27, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention
Rotavirus Gastroenteritis
Infections, Rotavirus
 Procedure: Blood sample collection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Gastroenteritis
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To estimate the incidence of severe rotavirus gastroenteritis (RV GE) and its associated complications in children < 5 years of age. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the gender, age of onset, severity of symptoms and underlying medical conditions in community and nosocomially acquired rotavirus infections [ Designated as safety issue: No ]
  • 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. [ Designated as safety issue: No ]
  • To estimate the incidence of liver involvement associated with RV GE and relate this to clinical symptoms in the population under surveillance. [ Designated as safety issue: No ]
  • 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. [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Stool sample, Blood sample


Enrollment: 642
Study Start Date: October 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A
Children hospitalised with community-acquired severe RV GE and children acquiring nosocomial severe RV GE.
 Procedure: Blood sample collection
not applicable

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children < 5 years of age in Sweden

Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489567

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00489567     History of Changes
Other Study ID Numbers: 109551
Study First Received: June 20, 2007
Last Updated: January 27, 2011
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by GlaxoSmithKline:
Rotavirus gastroenteritis

Additional relevant MeSH terms:
Gastroenteritis
Rotavirus Infections
Gastrointestinal Diseases
Digestive System Diseases
 Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 21, 2013