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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01311921
First received: March 8, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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
Enterovirus 71, Host Genetics, Social, Behavior, Environmental Factors

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Biospecimen Retention:   Samples With DNA

DNA,swab,blood


Estimated Enrollment: 200
Study Start Date: February 2011
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
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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,

Criteria

Inclusion Criteria:

- Enterovirus type 71

Exclusion Criteria:

- not Enterovirus type 71

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Kao-Pin,Hwang/Director of Pediatric Infectious Diseases, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01311921     History of Changes
Other Study ID Numbers: ChinaMUH
Study First Received: March 8, 2011
Last Updated: March 8, 2011
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on November 25, 2014