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
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2010-30-01
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
Location
GSK Investigational Site
Constanta, Romania, 900708
Status
Study Complete

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Finalized
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
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