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

Infections, Rotavirus Clinical Trial

Official title:

Hospital-based Surveillance to Estimate the Disease Burden of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01253967
• Other study ID #: 110436
• Status: Completed
• Phase: N/A
• First received: November 30, 2010
• Last updated: April 9, 2015
• Start date: February 2008
• Est. completion date: January 2010

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Minister of Health
• Study type: Observational

Clinical Trial Summary

The purpose of this hospital based study is to estimate the proportion of rotavirus gastroenteritis in children < 5 years of age in Romania.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1234
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroenteritis
• Infections, Rotavirus
• Rotavirus Infections

Intervention

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

Locations

Country	Name	City	State
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Cluj
Romania	GSK Investigational Site	Cluj Napoca
Romania	GSK Investigational Site	Constanta
Romania	GSK Investigational Site	Craiova
Romania	GSK Investigational Site	Sibiu
Romania	GSK Investigational Site	Timisoara

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of rotavirus gastroenteritis among all acute gastroenteritis hospitalisations of children < 5 years of age		At least 12 months from study start	No
Primary	Proportion of rotavirus gastroenteritis among all acute gastroenteritis emergency room visits for children < 5 years of age		At least 12 months from study start	No
Primary	Incidence of medical care associated rotavirus gastroenteritis among all hospitalised children < 5 years of age		At least 12 months from study start	No
Secondary	Age distribution of children with rotavirus gastroenteritis		At least 12 months from study start	No
Secondary	Percentage of rotavirus genotypes amongst all isolated strains in children < 5 years of age		At least 12 months from study start	No
Secondary	Potential risk factors for rotavirus gastroenteritis		At least 12 months from study start	No
Secondary	Rotavirus gastroenteritis associated costs		At least 12 months from study start	No
Secondary	Proportion of acute gastroenteritis among all hospitalisations of children < 5 years of age		At least 12 months from study start	No
Secondary	Proportion of community acquired acute gastroenteritis among all emergency room visits for children < 5 years of age		At least 12 months from study start	No
Secondary	Seasonal distribution (if appropriate) of rotavirus among all children < 5 years of age		At least 12 months from study start	No
Secondary	Severity of rotavirus among all children < 5 years of age		At least 12 months from study	No
Secondary	Proportion of rotavirus gastroenteritis among all hospitalisations of children < 5 years of age		At least 12 months from study start	No
Secondary	Proportion of community acquired rotavirus gastroenteritis among all emergency room visits for children < 5 years of age		At least 12 months from study start	No