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Completed

NCT Number: NCT01253967

Surveillance Study to Estimate the Proportion of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania

The purpose of this hospital based study is to estimate the proportion of rotavirus gastroenteritis in children < 5 years of age in Romania.

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Key information

Conditions

Infections, Rotavirus Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections RNA Virus Infections Reoviridae Infections Rotavirus Infections Virus Diseases

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Bucharest, Romania

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About this study

The study consist of a main study and a health economics study

Main study: The study will focus on three different groups of patients:

  • Subjects who are hospitalised for acute gastroenteritis.
  • Subjects who visit an emergency room for acute gastroenteritis.
  • Subjects who have rotavirus positive laboratory results and developed acute gastroenteritis at least 48 hours after hospitalisation.

Health economics study: for a subset of subjects, additional economic data will be gathered by completing a questionnaire

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A male or female child aged < 5 years at the time of admission. A child becomes ineligible on the day of her/his fifth birthday.
  • A subject, who during the study period:
  • Is hospitalised for acute gastroenteritis Or
  • Visits an emergency room for acute gastroenteritis Or
  • Has rotavirus positive laboratory results and develops acute gastroenteritis at least 48 hours after hospitalisation

Exclusion criteria

Not applicable

Treatment and study plan

Collection of stool samples

Procedure

Stool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped.

Health economics questionnaire

Other

For a subset of subjects, additional economic data will be gathered by completing a questionnaire

Primary outcomes

  1. Proportion of rotavirus gastroenteritis among all acute gastroenteritis hospitalisations of children < 5 years of age

    Time frame: At least 12 months from study start

  2. Proportion of rotavirus gastroenteritis among all acute gastroenteritis emergency room visits for children < 5 years of age

    Time frame: At least 12 months from study start

  3. Incidence of medical care associated rotavirus gastroenteritis among all hospitalised children < 5 years of age

    Time frame: At least 12 months from study start

Secondary outcomes

  1. Age distribution of children with rotavirus gastroenteritis

    Time frame: At least 12 months from study start

  2. Percentage of rotavirus genotypes amongst all isolated strains in children < 5 years of age

    Time frame: At least 12 months from study start

  3. Potential risk factors for rotavirus gastroenteritis

    Time frame: At least 12 months from study start

  4. Rotavirus gastroenteritis associated costs

    Time frame: At least 12 months from study start

  5. Proportion of acute gastroenteritis among all hospitalisations of children < 5 years of age

    Time frame: At least 12 months from study start

  6. Proportion of community acquired acute gastroenteritis among all emergency room visits for children < 5 years of age

    Time frame: At least 12 months from study start

  7. Seasonal distribution (if appropriate) of rotavirus among all children < 5 years of age

    Time frame: At least 12 months from study start

  8. Severity of rotavirus among all children < 5 years of age

    Time frame: At least 12 months from study

  9. Proportion of rotavirus gastroenteritis among all hospitalisations of children < 5 years of age

    Time frame: At least 12 months from study start

  10. Proportion of community acquired rotavirus gastroenteritis among all emergency room visits for children < 5 years of age

    Time frame: At least 12 months from study start

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Hospital-based Surveillance to Estimate the Disease Burden of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 6, 2010
Registry last updated
Apr 13, 2015

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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