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Surveillance of Rotavirus Gastroenteritis in Children <5 Years

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2005 by Soroka University Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01363726
First Posted: June 1, 2011
Last Update Posted: June 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Soroka University Medical Center
  Purpose
The purpose of this study is to monitor diarrheal disease and observe changes after the introduction of the rota vaccine.

Condition
Gastroenteritis Rotavirus Infections

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Surveillance of Rotavirus Gastroenteritis Among Children <5 Years of Age Visiting the Pediatric Emergency Room in Southern Israel

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30000
Study Start Date: October 2005
Groups/Cohorts
2
Jewish and Bedouin children < 5 years of age in southern Israel

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363726


Locations
Israel
Pediatric infectious disease unit Soroka U medical center Recruiting
Beer Sheva, Israel, 84101
Contact: David Greenberg, MD    97286400547    dudi@bgu.ac.il   
Contact: Oshrit Sabach    97286400547    sabacho@bgu.ac.il   
Principal Investigator: Ron Dagan, MD         
Sponsors and Collaborators
Soroka University Medical Center
  More Information

Responsible Party: pediatric infectious diseases unit,, Soroka U Medical center
ClinicalTrials.gov Identifier: NCT01363726     History of Changes
Other Study ID Numbers: sor415005ctil
First Submitted: May 30, 2011
First Posted: June 1, 2011
Last Update Posted: June 1, 2011
Last Verified: October 2005

Keywords provided by Soroka University Medical Center:
surveillance Rotavirus Gastroenteritis Children
< 5 years of age
southern Israel
Signed informed concent

Additional relevant MeSH terms:
Gastroenteritis
Rotavirus Infections
Gastrointestinal Diseases
Digestive System Diseases
Reoviridae Infections
RNA Virus Infections
Virus Diseases