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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RV GE Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stool sample | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Estimation of the proportion of RV GE among all acute GE emergency room visits among children <5 years of age. | Approximately 12 months | |
| Estimation of the proportion of RV GE among all acute GE hospitalisations among children <5 years of age. | Approximately 12 months | |
| Estimation of the incidence of nosocomial RV GE among all hospitalised children <5 years of age. | Approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
• Not applicable.
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Children < 5 years of age seen at the selected hospital sites for acute GE (e.g. subjects treated at the hospital or visiting the emergency room for an acute GE episode or developed acute GE at least 48 hours after hospitalisation) with a rapid screen positive test result to RV.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Athens | 104 46 | Greece | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24334153 | Derived | Konstantopoulos A, Tragiannidis A, Fouzas S, Kavaliotis I, Tsiatsou O, Michailidou E, Spanaki A, Mantagos S, Kafetzis D, Papaevangelou V, Gopala K, Holl K. Burden of rotavirus gastroenteritis in children <5 years of age in Greece: hospital-based prospective surveillance (2008-2010). BMJ Open. 2013 Dec 11;3(12):e003570. doi: 10.1136/bmjopen-2013-003570. |
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| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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Stool sample
| Data collection | Other | Logbook, Health Economic Questionnaire, Telephone call. |
|
| Approximately 12 months |
| Identification of prevalent genotypes of RV among children <5 years of age. | Approximately 12 months |
| Athens |
| 11527 |
| Greece |
| GSK Investigational Site | Heraklion, Crete | 71409 | Greece |
| GSK Investigational Site | Rio/Patras | 26500 | Greece |
| GSK Investigational Site | Thessaloniki | 546 38 | Greece |
| GSK Investigational Site | Thessaloniki | 54636 | Greece |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |