NCT01363726

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2011

Completed
Last Updated

June 1, 2011

Status Verified

October 1, 2005

First QC Date

May 30, 2011

Last Update Submit

May 31, 2011

Conditions

GastroenteritisRotavirus Infections

Keywords

surveillance Rotavirus Gastroenteritis Children< 5 years of agesouthern IsraelSigned informed concent

Outcome Measures

Primary Outcomes (1)

  • epidemiology of rota virus disease in southern Israel before and after the rota virus vaccine introduction

    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 Outcomes (1)

  • To compare rotavirus gastroenteritis among children <5 years of age from Jewish and Bedouin populations.

    7 years

Study Arms (1)

2

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

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Not all of the above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric infectious disease unit Soroka U medical center

Beersheba, 84101, Israel

RECRUITING

MeSH Terms

Conditions

GastroenteritisRotavirus Infections

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesReoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 30, 2011

First Posted

June 1, 2011

Study Start

October 1, 2005

Last Updated

June 1, 2011

Record last verified: 2005-10

Locations

IL(1)