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Completed

NCT Number: NCT00489567

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

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Key information

Conditions

Rotavirus Gastroenteritis Infections Infections, Rotavirus RNA Virus Infections Reoviridae Infections Rotavirus Infections Virus Diseases

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood sample collection

Procedure

Primary outcomes

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

Secondary outcomes

  1. To determine the gender, age of onset, severity of symptoms and underlying medical conditions in community and nosocomially acquired rotavirus infections

  2. 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.

  3. To estimate the incidence of liver involvement associated with RV GE and relate this to clinical symptoms in the population under surveillance.

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 21, 2007
Registry last updated
Jan 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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