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

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. Identifier: NCT01311921
Recruitment Status : Unknown
Verified March 2011 by China Medical University Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : March 10, 2011
Last Update Posted : March 10, 2011
Information provided by:
China Medical University Hospital

Brief Summary:
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.

Condition or disease
Enterovirus 71, Host Genetics, Social, Behavior, Environmental Factors

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
Estimated Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: 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 Start Date : February 2011

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Symptoms very like Enterovirus type 71 of hand, foot, and mouth disease or Herpangina,

Inclusion Criteria:

- Enterovirus type 71

Exclusion Criteria:

- not Enterovirus type 71

Responsible Party: Kao-Pin,Hwang/Director of Pediatric Infectious Diseases, China Medical University Hospital Identifier: NCT01311921     History of Changes
Other Study ID Numbers: ChinaMUH
First Posted: March 10, 2011    Key Record Dates
Last Update Posted: March 10, 2011
Last Verified: March 2011

Keywords provided by China Medical University Hospital:
enterovirus 71, host genetics, social, behavior, environmental factors

Additional relevant MeSH terms:
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases