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

This study is currently recruiting participants.
Verified by GlaxoSmithKline, September 2008

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00751686
  Purpose

Primary Objectives: a) to estimate the proportin of RV GE among all acute GE emergency room visits among children <5 years of age, b) to estimate the proportion of RV GE among all acute GE hospitalisations among children <5 years of age, c)to estimate the incidence of nosocomial RV GE among all hospitalised children <5 years of age.

All children <5 yeas of age presenting at the selected sites with acute GE will be asked to provide their stool sample to be tested for RV, only if their parents/guardians give their consent. All RV positive stool samples will be genotyped. Paretns/Guardians of enrolled subjects will be interviewed regarding their child´s diarrhoea. In addition, a subset of the hospitalised subjects´parents/guardians will be asked to complete a health economic questionnaire.


Condition Phase
Acute Gastroenteritis
Phase IV

MedlinePlus related topics:   Diarrhea    Gastroenteritis   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Prospective
Official Title:   Hospital-Based Surveillance to Estimate the Burden of Rotavirus Gastroenteritis in Children <5 Years of Age in Greece

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment:   960
Study Start Date:   July 2008

  Eligibility
Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Subjects should be <5 years of age and should be brought to the emergency room for acute GE or should develop acute GE at least 48 hours after hospitalisation. Only children with RV positive stool sample will be enrolled on the study.

  Contacts and Locations

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

Locations
Greece
GSK Clinical Trials call center     Recruiting
      Athens, Greece, 10446
      Contact: GSK Clinical Trials Call center     1-877-379-3718        
GSK Clinical Trials call center     Not yet recruiting
      Athens, Greece, 11527
      Contact: GSK Clinical Trials Call center     1-877-379-3718        
GSK Clinical Trials call center     Not yet recruiting
      Patras, Greece, 26500
      Contact: GSK Clinical Trials Call center     1-877-379-3718        
GSK Clinical Trials call center     Recruiting
      Crete, Greece, 71409
      Contact: GSK Clinical Trials Call center     1-877-379-3718        
GSK Clinical Trials call center     Recruiting
      Thessaloniki, Greece, 54638
      Contact: GSK Clinical Trials Call center     1-877-379-3718        
GSK Clinical Trials call center     Not yet recruiting
      Thessaloniki, Greece, 54636
      Contact: GSK Clinical Trials Call center     1-877-379-3718        

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     GSK Clinical Trials, MD     GlaxoSmithKline    
  More Information


Study ID Numbers:   109355, EPI-ROTA-109355
First Received:   September 11, 2008
Last Updated:   September 11, 2008
ClinicalTrials.gov Identifier:   NCT00751686
Health Authority:   Greece: National Organization of Medicines

Keywords provided by GlaxoSmithKline:
Acute gastroenteritis  
diarrhoea  
rotavirus  

Study placed in the following topic categories:
Digestive System Diseases
Diarrhea
Gastrointestinal Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on October 06, 2008




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