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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01917422 |
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Date of registration:
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28/09/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Specimens Testing Program of Dengue Antigen Detection Reagents
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Scientific title:
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Clinical Specimens Testing Program of Dengue Antigen Detection Reagents |
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Date of first enrolment:
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July 2012 |
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Target sample size:
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195 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01917422 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control
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Phase:
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N/A
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Countries of recruitment
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Taiwan
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Key inclusion & exclusion criteria
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Inclusion Criteria:A total of 95 cases and 100 controls (suspected cases(>50 %) and normal
subjects) are expected to enroll.
1. Case group: adults having a medical visit or admission due to dengue / dengue
hemorrhagic fever / dengue shock syndrome, and medical care of by (defined by CDC).
Any of the following positive test results for the case of 100 adults.
1. clinical specimens (blood) isolated and identified dengue virus.
2. clinical specimens positive for molecular detection of nucleic acids.
3. serological antigen (referring to non-structural proteins of dengue virus
non-structural protein 1, NS1) testing positive (based on the test of Bio-Rad
DENGUE NS1 Ag STRIP).
4. paired serum (restored period and acute phase), the dengue virus specific
immunoglobulin M or immunoglobulin G antibodies or negative or ? 4 times
increase.
2. Suspected cases: adults having medical visits or admissions due to infectious
disease, but their NS1 (based on the test of Bio-Rad DENGUE NS1 Ag STRIP),
immunoglobulin G,immunoglobulin M, real time-Polymerase chain reaction testing were
negative.
3. Control group: adults without having medical visits or admissions due to Fever. -
Exclusion Criteria:non-adult case -
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dengue Fever
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Primary Outcome(s)
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Clinical specimens testing program of dengue antigen detection reagents
[Time Frame: one year]
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Secondary ID(s)
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KMUHIRB-2012-03-14(II)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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