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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: May 2, 2013
Last verified: May 2013
History of Changes
  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:

MedlinePlus related topics: Gastroenteritis
U.S. FDA Resources

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01253967

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: May 2, 2013
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 May 23, 2013