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

NCT01253967 | Completed

• 1 other identifier: 110436
• Study Type: observational
• Target: 1,234
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Infections, Rotavirus

Keywords

Gastroenteritis; Hospital surveillance; Rotavirus gastroenteritis

Outcome Measures

Primary Outcomes (3)

• Proportion of rotavirus gastroenteritis among all acute gastroenteritis hospitalisations of children < 5 years of age

  At least 12 months from study start

• Proportion of rotavirus gastroenteritis among all acute gastroenteritis emergency room visits for children < 5 years of age

  At least 12 months from study start

• Incidence of medical care associated rotavirus gastroenteritis among all hospitalised children < 5 years of age

  At least 12 months from study start

Secondary Outcomes (10)

• Age distribution of children with rotavirus gastroenteritis

  At least 12 months from study start

• Percentage of rotavirus genotypes amongst all isolated strains in children < 5 years of age

  At least 12 months from study start

• Potential risk factors for rotavirus gastroenteritis

  At least 12 months from study start

• Rotavirus gastroenteritis associated costs

  At least 12 months from study start

• Proportion of acute gastroenteritis among all hospitalisations of children < 5 years of age

  At least 12 months from study start

Study Arms (3)

Group A

Subjects who are hospitalised for acute gastroenteritis

Procedure: Collection of stool samples; Other: Health economics questionnaire

Group B

Subjects who visit an emergency room for acute gastroenteritis

Procedure: Collection of stool samples; Other: Health economics 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; Other: Health economics questionnaire

Interventions

Collection of stool samples PROCEDURE

Stool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped.

Group A; Group B; Group C

Health economics questionnaire OTHER

For a subset of subjects, additional economic data will be gathered by completing a questionnaire

Group A; Group B; Group C

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

Bucharest, 021105, Romania

Location

GSK Investigational Site

Bucharest, Romania

Location

GSK Investigational Site

Cluj-Napoca, 400348, Romania

Location

GSK Investigational Site

Cluj-Napoca, Romania

Location

GSK Investigational Site

Constanța, 900708, Romania

Location

GSK Investigational Site

Craiova, Romania

Location

GSK Investigational Site

Sibiu, Romania

Location

GSK Investigational Site

Timișoara, Romania

Location

Related Publications (2)

• Benea OE, Streinu-Cercel A, Dorobat C, Rugina S, Negrutiu L, Cupsa A, Duiculescu D, Chiriac C, Itu C, Prisacariu LJ, Iosif I. Efficacy and safety of darunavir (Prezista((R))) with low-dose ritonavir and other antiretroviral medications in subtype F HIV-1 infected, treatment-experienced subjects in Romania: a post-authorization, open-label, one-cohort, non-interventional, prospective study. Germs. 2014 Sep 1;4(3):59-69. doi: 10.11599/germs.2014.1057. eCollection 2014 Sep.

  PMID: 25276665 DERIVED

• Anca IA, Furtunescu FL, Plesca D, Streinu-Cercel A, Rugina S, Holl K. Hospital-based surveillance to estimate the burden of rotavirus gastroenteritis in children below five years of age in Romania. Germs. 2014 Jun 2;4(2):30-40. doi: 10.11599/germs.2014.1053. eCollection 2014 Jun.

  PMID: 24967217 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool samples

MeSH Terms

Conditions

Rotavirus Infections; Gastroenteritis

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 6, 2010
• Study Start: February 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: April 13, 2015

Record last verified: 2015-04

Locations

RO (8)