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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00489567
First Posted: June 21, 2007
Last Update Posted: January 31, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
GlaxoSmithKline
  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:


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.

Secondary Outcome Measures:
  • 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
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489567


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

Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00489567     History of Changes
Other Study ID Numbers: 109551
First Submitted: June 20, 2007
First Posted: June 21, 2007
Last Update Posted: January 31, 2011
Last Verified: January 2011

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