Surveillance of Rotavirus Gastroenteritis in Children <5 Years

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2005 by Soroka University Medical Center.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Soroka University Medical Center

ClinicalTrials.gov Identifier:

NCT01363726

First received: May 30, 2011

Last updated: May 31, 2011

Last verified: October 2005

History of Changes

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:

MedlinePlus related topics: Gastroenteritis Rotavirus Infections

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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

Ages Eligible for Study:	up to 5 Years
Genders Eligible for Study:	Both
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:

Children < 5 years with
Gastro enteritis
Visiting the ER
Residents of southern Israel
Signed informed concent -

Exclusion Criteria:

Not all of the above

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	pediatric infectious diseases unit,, Soroka U Medical center
ClinicalTrials.gov Identifier:	NCT01363726 History of Changes
Other Study ID Numbers:	sor415005ctil
Study First Received:	May 30, 2011
Last Updated:	May 31, 2011
Health Authority:	Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on May 19, 2013

To Top