Gastroenteritis Clinical Trial
Official title:
Surveillance of Rotavirus Gastroenteritis Among Children <5 Years of Age Visiting the Pediatric Emergency Room in Southern Israel
NCT number | NCT01363726 |
Other study ID # | sor415005ctil |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | May 30, 2011 |
Last updated | May 31, 2011 |
Start date | October 2005 |
Verified date | October 2005 |
Source | Soroka University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ethics Commission |
Study type | Observational |
The purpose of this study is to monitor diarrheal disease and observe changes after the introduction of the rota vaccine.
Status | Recruiting |
Enrollment | 30000 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 5 Years |
Eligibility |
Inclusion Criteria: 1. Children < 5 years with 2. Gastro enteritis 3. Visiting the ER 4. Residents of southern Israel 5. Signed informed concent - Exclusion Criteria: Not all of the above |
Observational Model: Ecologic or Community, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Israel | Pediatric infectious disease unit Soroka U medical center | Beer Sheva |
Lead Sponsor | Collaborator |
---|---|
Soroka University Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | epidemiology of rota virus disease in southern Israel before and after the rota virus vaccine introduction | To assess the proportion of rotavirus gastroenteritis among children <5 years of age visiting the pediatric ER in southern Israel. To assess the hospitalization rate due to rotavirus. | 7 years | No |
Secondary | To compare rotavirus gastroenteritis among children <5 years of age from Jewish and Bedouin populations. | To compare rotavirus gastroenteritis among children <5 years of age from Jewish and Bedouin populations. | 7 years | No |
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