Surveillance Study to Estimate the Proportion of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01253967
First received: November 30, 2010
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

The purpose of this hospital based study is to estimate the proportion of rotavirus gastroenteritis in children < 5 years of age in Romania.


Condition Intervention
Infections, Rotavirus
Procedure: Collection of stool samples
Other: Health economics questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hospital-based Surveillance to Estimate the Disease Burden of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Proportion of rotavirus gastroenteritis among all acute gastroenteritis hospitalisations of children < 5 years of age [ Time Frame: At least 12 months from study start ] [ Designated as safety issue: No ]
  • Proportion of rotavirus gastroenteritis among all acute gastroenteritis emergency room visits for children < 5 years of age [ Time Frame: At least 12 months from study start ] [ Designated as safety issue: No ]
  • Incidence of medical care associated rotavirus gastroenteritis among all hospitalised children < 5 years of age [ Time Frame: At least 12 months from study start ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Age distribution of children with rotavirus gastroenteritis [ Time Frame: At least 12 months from study start ] [ Designated as safety issue: No ]
  • Percentage of rotavirus genotypes amongst all isolated strains in children < 5 years of age [ Time Frame: At least 12 months from study start ] [ Designated as safety issue: No ]
  • Potential risk factors for rotavirus gastroenteritis [ Time Frame: At least 12 months from study start ] [ Designated as safety issue: No ]
  • Rotavirus gastroenteritis associated costs [ Time Frame: At least 12 months from study start ] [ Designated as safety issue: No ]
  • Proportion of acute gastroenteritis among all hospitalisations of children < 5 years of age [ Time Frame: At least 12 months from study start ] [ Designated as safety issue: No ]
  • Proportion of community acquired acute gastroenteritis among all emergency room visits for children < 5 years of age [ Time Frame: At least 12 months from study start ] [ Designated as safety issue: No ]
  • Seasonal distribution (if appropriate) of rotavirus among all children < 5 years of age [ Time Frame: At least 12 months from study start ] [ Designated as safety issue: No ]
  • Severity of rotavirus among all children < 5 years of age [ Time Frame: At least 12 months from study ] [ Designated as safety issue: No ]
  • Proportion of rotavirus gastroenteritis among all hospitalisations of children < 5 years of age [ Time Frame: At least 12 months from study start ] [ Designated as safety issue: No ]
  • Proportion of community acquired rotavirus gastroenteritis among all emergency room visits for children < 5 years of age [ Time Frame: At least 12 months from study start ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Stool samples


Enrollment: 1234
Study Start Date: February 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A
Subjects who are hospitalised for acute gastroenteritis
Procedure: Collection of stool samples
Stool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped.
Other: Health economics questionnaire
For a subset of subjects, additional economic data will be gathered by completing a questionnaire
Group B
Subjects who visit an emergency room for acute gastroenteritis
Procedure: Collection of stool samples
Stool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped.
Other: Health economics questionnaire
For a subset of subjects, additional economic data will be gathered by completing a questionnaire
Group C
Subjects who have rotavirus positive laboratory results and developed acute gastroenteritis at least 48 hours after hospitalisation.
Procedure: Collection of stool samples
Stool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped.
Other: Health economics questionnaire
For a subset of subjects, additional economic data will be gathered by completing a questionnaire

Detailed Description:

The study consist of a main study and a health economics study

Main study: The study will focus on three different groups of patients:

  • Subjects who are hospitalised for acute gastroenteritis.
  • Subjects who visit an emergency room for acute gastroenteritis.
  • Subjects who have rotavirus positive laboratory results and developed acute gastroenteritis at least 48 hours after hospitalisation.

Health economics study: for a subset of subjects, additional economic data will be gathered by completing a questionnaire

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children < 5 years of age treated at a hospital site (subjects hospitalised with community acquired acute gastroenteritis, subjects who visited the emergency room for acute gastroenteritis or subjects with medical care associated rotavirus infection).

Criteria

Inclusion Criteria:

  • 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:

    • Is hospitalised for acute gastroenteritis Or
    • Visits an emergency room for acute gastroenteritis Or
    • Has rotavirus positive laboratory results and develops acute gastroenteritis at least 48 hours after hospitalisation

Exclusion Criteria:

Not applicable

  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: NCT01253967

Locations
Romania
GSK Investigational Site
Bucharest, Romania
GSK Investigational Site
Bucharest, Romania, 021105
GSK Investigational Site
Cluj, Romania, 400348
GSK Investigational Site
Cluj Napoca, Romania
GSK Investigational Site
Constanta, Romania, 900708
GSK Investigational Site
Craiova, Romania
GSK Investigational Site
Sibiu, Romania
GSK Investigational Site
Timisoara, Romania
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01253967     History of Changes
Other Study ID Numbers: 110436
Study First Received: November 30, 2010
Last Updated: January 9, 2014
Health Authority: Romania: Minister of Health

Keywords provided by GlaxoSmithKline:
Hospital surveillance
Rotavirus gastroenteritis
Gastroenteritis

Additional relevant MeSH terms:
Gastroenteritis
Rotavirus Infections
Gastrointestinal Diseases
Digestive System Diseases
Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on September 30, 2014