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The purpose of this hospital based study is to estimate the proportion of rotavirus gastroenteritis in children < 5 years of age in Romania.
The study consist of a main study and a health economics study
Main study: The study will focus on three different groups of patients:
Health economics study: for a subset of subjects, additional economic data will be gathered by completing a questionnaire
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Subjects who are hospitalised for acute gastroenteritis |
| |
| Group B | Subjects who visit an emergency room for acute gastroenteritis |
| |
| Group C | Subjects who have rotavirus positive laboratory results and developed acute gastroenteritis at least 48 hours after hospitalisation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bucharest | 021105 | Romania | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25276665 | Derived | 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. | |
| 24967217 |
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Stool samples
| Health economics questionnaire | Other | For a subset of subjects, additional economic data will be gathered by completing a questionnaire |
|
| 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 |
| Proportion of community acquired acute gastroenteritis among all emergency room visits for children < 5 years of age | At least 12 months from study start |
| Seasonal distribution (if appropriate) of rotavirus among all children < 5 years of age | At least 12 months from study start |
| Severity of rotavirus among all children < 5 years of age | At least 12 months from study |
| Proportion of rotavirus gastroenteritis among all hospitalisations of children < 5 years of age | At least 12 months from study start |
| Proportion of community acquired rotavirus gastroenteritis among all emergency room visits for children < 5 years of age | At least 12 months from study start |
| Bucharest |
| Romania |
| GSK Investigational Site | Cluj-Napoca | 400348 | Romania |
| GSK Investigational Site | Cluj-Napoca | Romania |
| GSK Investigational Site | Constanța | 900708 | Romania |
| GSK Investigational Site | Craiova | Romania |
| GSK Investigational Site | Sibiu | Romania |
| GSK Investigational Site | Timișoara | Romania |
| 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. |
| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| D005759 | Gastroenteritis |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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