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Sponsored by: |
GlaxoSmithKline |
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00751686 |
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 |
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 |
Ages Eligible for Study: | up to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
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 |
GlaxoSmithKline |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
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 |
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