We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01253967
First Posted: December 6, 2010
Last Update Posted: April 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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 ]
  • 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 ]
  • Incidence of medical care associated rotavirus gastroenteritis among all hospitalised children < 5 years of age [ Time Frame: At least 12 months from study start ]

Secondary Outcome Measures:
  • Age distribution of children with rotavirus gastroenteritis [ Time Frame: At least 12 months from study start ]
  • Percentage of rotavirus genotypes amongst all isolated strains in children < 5 years of age [ Time Frame: At least 12 months from study start ]
  • Potential risk factors for rotavirus gastroenteritis [ Time Frame: At least 12 months from study start ]
  • Rotavirus gastroenteritis associated costs [ Time Frame: At least 12 months from study start ]
  • Proportion of acute gastroenteritis among all hospitalisations of children < 5 years of age [ Time Frame: At least 12 months from study start ]
  • 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 ]
  • Seasonal distribution (if appropriate) of rotavirus among all children < 5 years of age [ Time Frame: At least 12 months from study start ]
  • Severity of rotavirus among all children < 5 years of age [ Time Frame: At least 12 months from study ]
  • Proportion of rotavirus gastroenteritis among all hospitalisations of children < 5 years of age [ Time Frame: At least 12 months from study start ]
  • 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01253967


Locations
Romania
GSK Investigational Site
Bucharest, Romania, 021105
GSK Investigational Site
Bucharest, Romania
GSK Investigational Site
Cluj Napoca, Romania
GSK Investigational Site
Cluj, Romania, 400348
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01253967     History of Changes
Other Study ID Numbers: 110436
First Submitted: November 30, 2010
First Posted: December 6, 2010
Last Update Posted: April 13, 2015
Last Verified: April 2015

Keywords provided by GlaxoSmithKline:
Gastroenteritis
Hospital surveillance
Rotavirus gastroenteritis

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