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Completed

NCT Number: NCT01202201

A Retrospective Survey of the Burden of Rotavirus Gastroenteritis (RV GE) and Nosocomial RV GE in Japan

The purpose of this study is to evaluate the epidemiology and baseline disease burden of rotavirus gastroenteritis in children < 6 years of age, in Japan.

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Key information

Conditions

Nosocomial Rotavirus Gastroenteritis Rotavirus Gastroenteritis

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Observational

About this study

This is a retrospective database study wherein data on children who have been diagnosed with acute gastroenteritis or rotavirus gastroenteritis will be collected from the electronic admission database or any other applicable database of the participating hospitals.

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 <6 years at the time of admission in hospital. A child will become ineligible on the day of her/his sixth birthday.
  • A subject who is hospitalized with any acute gastroenteritis or rotavirus gastroenteritis during the survey period.

Exclusion criteria

  • Participants of any kind of rotavirus vaccine clinical trial.

Treatment and study plan

Database analysis

Other

Review and collect data from database (electronic admission database or any other applicable database of the hospital)

Primary outcomes

  1. Occurrence of acute gastroenteritis among all hospitalized children aged <6 years

    Time frame: At least 24 months (from 01 January 2008 to 31 December 2009)

  2. Occurrence of rotavirus gastroenteritis among all hospitalized children aged <6 years

    Time frame: At least 24 months (from 01 January 2008 to 31 December 2009)

  3. Occurrence of rotavirus gastroenteritis among all acute gastroenteritis hospitalizations in children aged <6 years

    Time frame: At least 24 months (from 01 January 2008 to 31 December 2009)

Secondary outcomes

  1. Occurrence of nosocomial rotavirus gastroenteritis among all hospitalized children aged <6 years

    Time frame: At least 24 months (from 01 January 2008 to 31 December 2009)

  2. Occurrence of nosocomial rotavirus gastroenteritis among all hospitalizations with rotavirus gastroenteritis in children aged <6 years

    Time frame: At least 24 months (from 01 January 2008 to 31 December 2009)

  3. Prolongation of hospitalization of patients with nosocomial rotavirus gastroenteritis

    Time frame: At least 24 months (from 01 January 2008 to 31 December 2009)

  4. Occurrence of rotavirus gastroenteritis hospitalization and nosocomial rotavirus gastroenteritis hospitalization among children <6 years of age, stratified by age

    Time frame: At least 24 months (from 01 January 2008 to 31 December 2009)

  5. Seasonal distribution (monthly) of rotavirus gastroenteritis infection

    Time frame: At least 24 months (from 01 January 2008 to 31 December 2009)

  6. Age (monthly) specific data of all the outcome measures, for children <12 months of age

    Time frame: At least 24 months (from 01 January 2008 to 31 December 2009)

  7. Number of hospitalizations with rotavirus gastroenteritis and other vaccine-preventable infectious diseases such as influenza, mumps and varicella among children <6 years of age

    Time frame: At least 24 months (from 01 January 2008 to 31 December 2009)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Retrospective Survey of the Burden of Rotavirus Gastroenteritis (RV GE) and Nosocomial RV GE in Children <6 Years of Age in Japan

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 15, 2010
Registry last updated
Jun 7, 2017

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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