NCT01917422

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 6, 2013

Completed
Last Updated

August 6, 2013

Status Verified

July 1, 2013

Enrollment Period

11 months

First QC Date

September 28, 2012

Last Update Submit

August 4, 2013

Conditions

Dengue Fever

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The samples are obtained from the Kaohsiung Medical University Chung-Ho Memorial Hospital in Kaohsiung, Taiwan.

You may qualify if:

  • 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.
  • clinical specimens (blood) isolated and identified dengue virus.
  • clinical specimens positive for molecular detection of nucleic acids.
  • 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).
  • paired serum (restored period and acute phase), the dengue virus specific immunoglobulin M or immunoglobulin G antibodies or negative or ≧ 4 times increase.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaoshing Medical University Chung-Ho Memorial Hospital

Kaoshiung, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

no biospecimens are to be retained

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2012

First Posted

August 6, 2013

Study Start

July 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

August 6, 2013

Record last verified: 2013-07

Locations

TW(1)