Surveillance of Rotavirus Gastroenteritis in Children <5 Years

• Conditions: Gastroenteritis; Rotavirus Infections

• Registration Number: NCT01363726
• Lead Sponsor: Soroka University Medical Center

Brief Summary

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

Detailed 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

Study Timeline

• Status Verified: 2005-10
• Study Start: 2005-10
• Study First Submitted: 2011-05-30
• Study First Submitted QC: 2011-05-31
• Last Update Submitted: 2011-05-31
• Study First Posted: 2011-06-01
• Last Update Posted: 2011-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
epidemiology of rota virus disease in southern Israel before and after the rota virus vaccine introduction	7 years	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.

Secondary Outcome Measures

Name	Time	Method
To compare rotavirus gastroenteritis among children <5 years of age from Jewish and Bedouin populations.	7 years	To compare rotavirus gastroenteritis among children \<5 years of age from Jewish and Bedouin populations.

Trial Locations

Locations (1)

Pediatric infectious disease unit Soroka U medical center; 🇮🇱 Beer Sheva, Israel