Surveillance of Rotavirus Gastroenteritis in Children <5 Years

Gastroenteritis Clinical Trial

Official title:

Surveillance of Rotavirus Gastroenteritis Among Children <5 Years of Age Visiting the Pediatric Emergency Room in Southern Israel

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01363726
• Other study ID #: sor415005ctil
• Status: Recruiting
• Phase: N/A
• First received: May 30, 2011
• Last updated: May 31, 2011
• Start date: October 2005

Study information

• Verified date: October 2005
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to monitor diarrheal disease and observe changes after the introduction of the rota vaccine.

Description:

Monitoring of diarrheal disease and observe changes after the introduction of the rota vaccine Comparing the epidemiology in Jewish and Bedouin population before and after the introduction of the rota vaccine into the national immunization program

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30000
• 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

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroenteritis
• Rotavirus Infections

Locations

Country	Name	City	State
Israel	Pediatric infectious disease unit Soroka U medical center	Beer Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

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