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Trial record 58 of 97 for:    "Dengue Hemorrhagic Fever"

Clinical Specimens Testing Program of Dengue Antigen Detection Reagents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01917422
Recruitment Status : Completed
First Posted : August 6, 2013
Last Update Posted : August 6, 2013
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary:
Dengue virus serological reagent, included antigen and antiserum, is a serum test for identification of serum antibodies to dengue virus.

Condition or disease
Dengue Fever

Detailed Description:
The developed assay helps to diagnose diseases caused by this virus and to provide information on disease epidemiology. This virus is mainly transmitted by mosquito bites to people and will make flu-like symptoms, including fever, fatigue, cough and headache, which can cause severe hemorrhagic dengue.

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Study Type : Observational
Actual Enrollment : 195 participants
Observational Model: Case Control
Official Title: Clinical Specimens Testing Program of Dengue Antigen Detection Reagents
Study Start Date : July 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue




Primary Outcome Measures :
  1. Clinical specimens testing program of dengue antigen detection reagents [ Time Frame: one year ]
    Calculate two products of the dengue immune detection accuracy, sensitivity, specificity, false positive, false negative.


Biospecimen Retention:   Samples With DNA
no biospecimens are to be retained


Information from the National Library of Medicine

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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: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 -

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): NCT01917422


Locations
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Taiwan
Kaoshing Medical University Chung-Ho Memorial Hospital
Kaoshiung, Taiwan
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital

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Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT01917422     History of Changes
Other Study ID Numbers: KMUHIRB-2012-03-14(II)
First Posted: August 6, 2013    Key Record Dates
Last Update Posted: August 6, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
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Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral