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

NCT01202201 | Completed

• 1 other identifier: 114131
• Study Type: observational
• Target: 13,767
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Nosocomial Rotavirus Gastroenteritis; Rotavirus Gastroenteritis

Outcome Measures

Primary Outcomes (3)

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

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

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

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

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

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

Secondary Outcomes (7)

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

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

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

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

• Prolongation of hospitalization of patients with nosocomial rotavirus gastroenteritis

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

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

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

• Seasonal distribution (monthly) of rotavirus gastroenteritis infection

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

Study Arms (1)

Study Cohort

Subjects hospitalized with acute gastroenteritis or rotavirus gastroenteritis

Other: Database analysis

Interventions

Database analysis OTHER

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

Study Cohort

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Participants of any kind of rotavirus vaccine clinical trial.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• Tajiri H, Takeuchi Y, Takano T, Ohura T, Inui A, Yamamoto K, Higashidate Y, Kawashima H, Toyoda S, Ushijima K, Ramakrishnan G, Rosenlund M, Holl K. The burden of rotavirus gastroenteritis and hospital-acquired rotavirus gastroenteritis among children aged less than 6 years in Japan: a retrospective, multicenter epidemiological survey. BMC Pediatr. 2013 May 22;13:83. doi: 10.1186/1471-2431-13-83.

  PMID: 23697664 DERIVED

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 15, 2010
• Study Start: September 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: June 7, 2017

Record last verified: 2017-06