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

NCT ID: NCT01202201

Last Updated: 2017-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13767 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nosocomial Rotavirus Gastroenteritis Rotavirus Gastroenteritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Study Cohort

Subjects hospitalized with acute gastroenteritis or rotavirus gastroenteritis

Database analysis

Intervention Type OTHER

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

Interventions

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Database analysis

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

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

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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.

Reference Type DERIVED
PMID: 23697664 (View on PubMed)

Other Identifiers

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114131

Identifier Type: -

Identifier Source: org_study_id

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