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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01311921
Other study ID # ChinaMUH
Secondary ID
Status Enrolling by invitation
Phase N/A
First received March 8, 2011
Last updated March 8, 2011
Start date February 2011

Study information

Verified date March 2011
Source China Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- Enterovirus type 71

Exclusion Criteria:

- not Enterovirus type 71

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
China Medical University Hospital