Surveillance of Rotavirus Gastroenteritis in Children <5 Years

• ClinicalTrials.gov Identifier: NCT01363726
• Recruitment Status: Unknown
• First Posted: June 1, 2011
• Last Update Posted: June 1, 2011
• Sponsor: Soroka University Medical Center
• Information provided by: Soroka University Medical Center

Tracking Information

• First Submitted Date: May 30, 2011
• First Posted Date: June 1, 2011
• Last Update Posted Date: June 1, 2011
• Study Start Date: October 2005
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: May 31, 2011)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 31, 2011)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Surveillance of Rotavirus Gastroenteritis in Children <5 Years
• Official Title: Surveillance of Rotavirus Gastroenteritis Among Children <5 Years of Age Visiting the Pediatric Emergency Room in Southern Israel
• 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 Type: Observational
• Study Design: Observational Model: Ecologic or Community; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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

Condition

• Gastroenteritis
• Rotavirus Infections

• Intervention: Not Provided

Study Groups/Cohorts

2

Jewish and Bedouin children < 5 years of age in southern Israel

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 31, 2011): 30000
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 5 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT01363726
• Other Study ID Numbers: sor415005ctil
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: pediatric infectious diseases unit,, Soroka U Medical center
• Original Responsible Party: Same as current
• Current Study Sponsor: Soroka University Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Soroka University Medical Center
• Verification Date: October 2005