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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01202201
First received: September 14, 2010
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Nosocomial Rotavirus Gastroenteritis
Viral Gastroenteritis Due to Rotavirus
Other: Database analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Survey of the Burden of Rotavirus Gastroenteritis (RV GE) and Nosocomial RV GE in Children <6 Years of Age in Japan

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Prolongation of hospitalization of patients with nosocomial rotavirus gastroenteritis [ Time Frame: At least 24 months (from 01 January 2008 to 31 December 2009) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Seasonal distribution (monthly) of rotavirus gastroenteritis infection [ Time Frame: At least 24 months (from 01 January 2008 to 31 December 2009) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 13767
Study Start Date: September 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Study Cohort
Subjects hospitalized with acute gastroenteritis or rotavirus gastroenteritis
Other: Database analysis
Review and collect data from database (electronic admission database or any other applicable database of the hospital)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children <6 years of age hospitalized with acute gastroenteritis or rotavirus gastroenteritis in any of the participating hospitals

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202201

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

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01202201     History of Changes
Other Study ID Numbers: 114131
Study First Received: September 14, 2010
Last Updated: March 31, 2011
Health Authority: Japan: MHLW (Ministry of Health, Labour and Welfare)

Additional relevant MeSH terms:
Gastroenteritis
Enteritis
Adenovirus Infections, Human
Enterovirus Infections
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adenoviridae Infections
DNA Virus Infections
Virus Diseases
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on August 19, 2014