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

To Estimate the Burden of Rotavirus Gastroenteritis (RV GE) in Children < 5 Years of Age in Greece

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.

Study Overview

• Status: Completed
• Conditions: Rotavirus Gastroenteritis
• Intervention / Treatment: Procedure: Stool sample; Other: Data collection

• Study Type: Observational
• Enrollment (Actual): 128

Contacts and Locations

Study Locations

• Greece
  • 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, 54636
    • GSK Investigational Site
  • Thessaloniki, Greece, 546 38
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RV GE Group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Estimation of the proportion of RV GE among all acute GE emergency room visits among children <5 years of age.	Approximately 12 months
Estimation of the proportion of RV GE among all acute GE hospitalisations among children <5 years of age.	Approximately 12 months
Estimation of the incidence of nosocomial RV GE among all hospitalised children <5 years of age.	Approximately 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Determination of the age of the children, disease severity, and the seasonal distribution of RV GE among children <5 years of age.	Approximately 12 months
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.	Approximately 12 months
Identification of prevalent genotypes of RV among children <5 years of age.	Approximately 12 months

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Konstantopoulos A, Tragiannidis A, Fouzas S, Kavaliotis I, Tsiatsou O, Michailidou E, Spanaki A, Mantagos S, Kafetzis D, Papaevangelou V, Gopala K, Holl K. Burden of rotavirus gastroenteritis in children <5 years of age in Greece: hospital-based prospective surveillance (2008-2010). BMJ Open. 2013 Dec 11;3(12):e003570. doi: 10.1136/bmjopen-2013-003570.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: September 11, 2008
• First Submitted That Met QC Criteria: September 11, 2008
• First Posted (Estimate): September 12, 2008

Study Record Updates

• Last Update Posted (Estimate): February 18, 2013
• Last Update Submitted That Met QC Criteria: February 14, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Children; Gastroenteritis; Burden; Rotavirus; Greece; < 5 years
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: 109355