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

Rotavirus Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00751686
• Other study ID #: 109355
• Status: Completed
• Phase: N/A
• First received: September 11, 2008
• Last updated: February 14, 2013
• Start date: July 2008
• Est. completion date: March 2010

Study information

• Verified date: February 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Medicines Agency
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroenteritis
• Rotavirus Gastroenteritis

Intervention

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.

Locations

Country	Name	City	State
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Heraklion, Crete
Greece	GSK Investigational Site	Rio/Patras
Greece	GSK Investigational Site	Thessaloniki
Greece	GSK Investigational Site	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimation of the proportion of RV GE among all acute GE emergency room visits among children <5 years of age.		Approximately 12 months	No
Primary	Estimation of the proportion of RV GE among all acute GE hospitalisations among children <5 years of age.		Approximately 12 months	No
Primary	Estimation of the incidence of nosocomial RV GE among all hospitalised children <5 years of age.		Approximately 12 months	No
Secondary	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	No
Secondary	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	No
Secondary	Identification of prevalent genotypes of RV among children <5 years of age.		Approximately 12 months	No