Text Size

Estimation of the Burden of Rotavirus Gastroenteritis (RV GE) in Children Less Than 5 Years in Greece

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00751686
First received: September 11, 2008
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to measure the disease burden from RV GE among children less than 5 years of age using hospital surveillance data. In addition, data collected will determine the seasonal distribution, disease severity, age distribution of RV GE. From an economic standpoint, the cost and impact of RV will also be assessed.


Condition Intervention
Rotavirus Gastroenteritis
 Procedure: Stool sample
Other: Data collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: To Estimate the Burden of Rotavirus Gastroenteritis (RV GE) in Children < 5 Years of Age in Greece

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Estimation of the proportion of RV GE among all acute GE emergency room visits among children <5 years of age. [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
  • Estimation of the proportion of RV GE among all acute GE hospitalisations among children <5 years of age. [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
  • Estimation of the incidence of nosocomial RV GE among all hospitalised children <5 years of age. [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determination of the age of the children, disease severity, and the seasonal distribution of RV GE among children <5 years of age. [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
  • Assessing the costs related to the episodes of RV GE, by the completion of the Health Economic Questionnaire (interview with the parent for a subset of subjects) and the cost checklist provided by the hospital's site staff. [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
  • Identification of prevalent genotypes of RV among children <5 years of age. [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Stool sample


Enrollment: 128
Study Start Date: July 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
RV GE Group
Not applicable
 Procedure: Stool sample
Collection of the stool at least 48 hours after hospitalisation. Stool samples should be obtained preferably within 4 and no later than 10 days after the onset of the GE symptoms.
Other: Data collection
Logbook, Health Economic Questionnaire, Telephone call.

  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 seen at the selected hospital sites for acute GE (e.g. subjects treated at the hospital or visiting the emergency room for an acute GE episode or developed acute GE at least 48 hours after hospitalisation) with a rapid screen positive test result to RV.

Criteria

Inclusion Criteria:

  • A male or female child < 5 years of age at the time of the visit (a child becomes ineligible on the day of her/his 5th birthday).
  • Child is brought to the emergency room for acute GE during the study period or develop acute GE at least 48 hours after hospitalisation.
  • Written informed consent obtained from the parent/guardian of the subject.
  • Children with RV positive stool sample will be enrolled in the study.

Exclusion Criteria:

• Not applicable.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751686

Locations
Greece
GSK Investigational Site
Athens, Greece, 11527
GSK Investigational Site
Athens, Greece, 104 46
GSK Investigational Site
Heraklion, Crete, Greece, 71409
GSK Investigational Site
Rio/Patras, Greece, 26500
GSK Investigational Site
Thessaloniki, Greece, 546 38
GSK Investigational Site
Thessaloniki, Greece, 54636
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00751686     History of Changes
Other Study ID Numbers: 109355
Study First Received: September 11, 2008
Last Updated: February 14, 2013
Health Authority: Greece: National Medicines Agency

Keywords provided by GlaxoSmithKline:
Gastroenteritis
Burden
Rotavirus
 < 5 years
Greece
Children

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 21, 2013