Clinical Specimens Testing Program of Dengue Antigen Detection Reagents

Dengue Fever Clinical Trial

Official title:

Clinical Specimens Testing Program of Dengue Antigen Detection Reagents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917422
• Other study ID #: KMUHIRB-2012-03-14(II)
• Status: Completed
• Phase: N/A
• First received: September 28, 2012
• Last updated: August 4, 2013
• Start date: July 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 -

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Dengue
• Dengue Fever

Locations

Country	Name	City	State
Taiwan	Kaoshing Medical University Chung-Ho Memorial Hospital	Kaoshiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical specimens testing program of dengue antigen detection reagents	Calculate two products of the dengue immune detection accuracy, sensitivity, specificity, false positive, false negative.	one year	Yes