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The Pilot Study of Chikungunya Virus Infections in Southern Taiwan

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ClinicalTrials.gov Identifier: NCT02174341
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital

Study Description
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Brief Summary:
This test is to be collected during the dengue outbreak samples, including samples back in the past and forward to close the case, investigating the prevalence of serum Chikungunya virus infection, and against those suspected dengue fever, Chikungunya disease-related tests conducted to clarify dengue and Chikungunya disease of clinical judgment, rapid method to detect Chikungunya virus and then develop.

Condition or disease
Chikungunya Fever

Detailed Description:

During the execution of this project was ended March 1, 2012 to December 31, 2015, is expected to gather 300 suspected dengue infection, of whom 150 dengue-negative test results, test results of 150 dengue positive. And closed the case into prospective and retrospective analysis of the last sample into two parts.

Case closed after part of a prospective analysis of the study, subjects were required to complete consent forms and collect 20 ml blood samples, blood samples will be checked to identify dengue and Chikungunya disease associated serum antigen-antibody reaction , PCR (polymerase chain reaction) test and sequence analysis and pathogen identification and separation, in order to identify the source of infection difference. In addition, retrospective analysis of the last part of the specimen, sucked "after the health of the host track dengue infection, host immune regulation changes, and possible interactions with viral hepatitis" (KMUH-IRB-960195) collected by the inspection plan body, the number of samples included in the plan to close the case, and contact with the subjects, changes to inform the content of the plan to re-sign the consent form.

Study Design
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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Investigate the Prevalence of Serum Chikungunya Virus Infection, and Against Those Suspected Dengue Fever, Chikungunya Disease-related Tests Conducted
Study Start Date : April 2012
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. For persons with suspected dengue fever, Chikungunya disease-related testing conducted to clarify the clinical dengue and Chikungunya disease of judgment [ Time Frame: 75 months ]
    The project expects to help physicians understand overview of Taiwan Chikungunya epidemic diseases and assisting their clinical judgment. Hope to establish a complete ilk disease and clinical information, and then establish a rapid detection of Chikungunya virus.


Biospecimen Retention:   Samples With DNA
blood samples

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The samples are obtained from the Kaohsiung Medical University Chung-Ho Memorial Hospital in Kaohsiung, Taiwan.
Criteria

Inclusion Criteria:

  • Suspected of being infected with dengue fever

Exclusion Criteria:

  • none
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174341


Locations
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Taiwan
Kaoshing Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
More Information
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Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT02174341    
Other Study ID Numbers: KMUH-IRB-20110428
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
Chikungunya fever
Chikungunya Virus
Additional relevant MeSH terms:
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Virus Diseases
Chikungunya Fever
Fever
Infections
Body Temperature Changes
 Alphavirus Infections
Arbovirus Infections
Vector Borne Diseases
Togaviridae Infections
RNA Virus Infections