- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01311921
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
Status
Unknown
Detailed Description
The specific aims are to find factors associated with different severe/fatal incidences in different areas of Taiwan. We will do
- 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
- 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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChinaMUH
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