Children's Susceptibility to Enterovirus 71 in Different Areas of Taiwan (DMR100-IRB-010)

March 8, 2011 updated by: China Medical University Hospital

The Specific Aims Are to Find Factors Associated With Different Severe/Fatal Incidences in Different Areas of Taiwan. We Will do 1. Comparison of Gene Variants in EV71 Cases With Different Severity and Normal Children in Different Areas of Taiwan to Find Susceptible Genes and Genetic Polymorphism Related to the Clinical Outcomes 2. Social, Behavioral and Environmental Factors Related to EV71 Infections in Different Areas of Taiwan

EV71 has caused large epidemics with lots of fatal cases and cases with sequelae. However, the clinical syndromes and severity of the same EV71 strain are very diverse, ranging from asymptomatic (71%) to fatal (0.05%) disease, and the pathogenesis remains unknown. In addition, the severe or fatal case incidence varies significantly differently in different areas of Taiwan. Although some viral virulence studies were performed, no clear viral virulence factor has been found. Therefore, host factors may be important to the clinical outcomes of EV71 infections. In addition, there were significantly different incidences of severe or fatal cases in different areas of Taiwan, for example, significantly more fatal or severe cases occurred in the central or southern Taiwan in comparison with in northern Taiwan. Whether this is related to host factors, social, behavioral or environmental factors remains unanswered. To find the most important factors associated with EV71 susceptibility, a thorough study involving genetics, social, behavioral or environmental factors among different areas of Taiwan is warranted and the findings will provide future prevention of EV71 and give help on early precaution and treatment of EV71.

Study Overview

Detailed Description

The specific aims are to find factors associated with different severe/fatal incidences in different areas of Taiwan. We will do

  1. Comparison of gene variants in EV71 cases with different severity and normal children in different areas of Taiwan to find susceptible genes and genetic polymorphism related to the clinical outcomes
  2. Social, behavioral and environmental factors related to EV71 infections in different areas of Taiwan

Study Type

Observational

Enrollment (Anticipated)

200

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

1 day to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Symptoms very like Enterovirus type 71 of hand, foot, and mouth disease or Herpangina,

Description

Inclusion Criteria:

- Enterovirus type 71

Exclusion Criteria:

- not Enterovirus type 71

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

Collaborators and Investigators

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

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

February 1, 2011

Study Registration Dates

First Submitted

March 8, 2011

First Submitted That Met QC Criteria

March 8, 2011

First Posted (Estimate)

March 10, 2011

Study Record Updates

Last Update Posted (Estimate)

March 10, 2011

Last Update Submitted That Met QC Criteria

March 8, 2011

Last Verified

March 1, 2011

More Information

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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