Surveillance of Rotavirus Gastroenteritis in Children <5 Years

May 31, 2011 updated by: Soroka University Medical Center

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

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

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Sheva, Israel, 84101
        • Recruiting
        • Pediatric infectious disease unit Soroka U medical center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ron Dagan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Survieillance of Rotavirus Gastroenteritis Among Children Bedouin and Jewish < 5 years with gastro enteritis visiting the ER in southern Israel

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
2
Jewish and Bedouin children < 5 years of age in southern Israel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
epidemiology of rota virus disease in southern Israel before and after the rota virus vaccine introduction
Time Frame: 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.
7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare rotavirus gastroenteritis among children <5 years of age from Jewish and Bedouin populations.
Time Frame: 7 years
To compare rotavirus gastroenteritis among children <5 years of age from Jewish and Bedouin populations.
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Registration Dates

First Submitted

May 30, 2011

First Submitted That Met QC Criteria

May 31, 2011

First Posted (Estimate)

June 1, 2011

Study Record Updates

Last Update Posted (Estimate)

June 1, 2011

Last Update Submitted That Met QC Criteria

May 31, 2011

Last Verified

October 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sor415005ctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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