Last updated: 11/03/2018 11:02:34

Surveillance study to estimate the proportion of rotavirus gastroenteritis in children < 5 years of age in Romania

GSK study ID
110436
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Hospital-based surveillance to estimate the disease burden of rotavirus gastroenteritis in children < 5 years of age in Romania
Trial description: The purpose of this hospital based study is to estimate the proportion of rotavirus gastroenteritis in children < 5 years of age in Romania.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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

Timeframe: At least 12 months from study start

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

Timeframe: At least 12 months from study start

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

Timeframe: At least 12 months from study start

Secondary outcomes:

Age distribution of children with rotavirus gastroenteritis

Timeframe: At least 12 months from study start

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

Timeframe: At least 12 months from study start

Potential risk factors for rotavirus gastroenteritis

Timeframe: At least 12 months from study start

Rotavirus gastroenteritis associated costs

Timeframe: At least 12 months from study start

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

Timeframe: At least 12 months from study start

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

Timeframe: At least 12 months from study start

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

Timeframe: At least 12 months from study start

Severity of rotavirus among all children < 5 years of age

Timeframe: At least 12 months from study

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

Timeframe: At least 12 months from study start

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

Timeframe: At least 12 months from study start

Interventions:
  • Procedure/surgery: Collection of stool samples
  • Other: Health economics questionnaire
  • Enrollment:
    1234
    Primary completion date:
    2010-30-01
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Rotavirus
    Product
    SB444563
    Collaborators
    Not applicable
    Study date(s)
    February 2008 to January 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable - 5 years
    Accepts healthy volunteers
    No
    • 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:
    • Not applicable

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Sibiu, Romania
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cluj, Romania, 400348
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bucharest, Romania
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cluj Napoca, Romania
    Status
    Study Complete
    Location
    GSK Investigational Site
    Craiova, Romania
    Status
    Study Complete
    Location
    GSK Investigational Site
    Timisoara, Romania
    Status
    Study Complete
    Showing 1 - 6 of 7 Results

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    2010-30-01
    Actual study completion date
    2010-30-01

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website