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Sample Collection to Evaluate an Investigational Instrument for the Detection of Respiratory Viruses in Nasopharyngeal Swabs

Sponsor
GenMark Diagnostics (Industry)
Overall Status
Completed
CT.gov ID
NCT01806285
Collaborator
(none)
205
Enrollment
33
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this sample collection study is to prospectively collect respiratory viral clinical samples, conduct standard of care comparator testing and archive the collected residual samples for future testing in order to establish the clinical performance characteristics of the investigational instrument.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    205 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Study Start Date :
    Feb 1, 2013
    Actual Primary Completion Date :
    May 1, 2014
    Actual Study Completion Date :
    Nov 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with Respiratory Symptoms

    Outcome Measures

    Primary Outcome Measures

    1. Sample collection study only [prospective sample collection]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • The specimen is a nasopharyngeal swab.

    • The specimen is from a pediatric or adult male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long term care facility.

    • The specimen is from a patient exhibiting clinical signs and symptoms of respiratory tract infection such as fever, sore throat, shortness of breath, bronchitis, bronchiolitis, and pneumonia.

    Exclusion Criteria:

    • The specimen is not a nasopharyngeal swab.

    • The specimen is from an individual who does not exhibit clinical signs and symptoms of respiratory tract infection.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • GenMark Diagnostics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GenMark Diagnostics
    ClinicalTrials.gov Identifier:
    NCT01806285
    Other Study ID Numbers:
    • CTP0001
    First Posted:
    Mar 7, 2013
    Last Update Posted:
    Dec 28, 2015
    Last Verified:
    Dec 1, 2015
    Keywords provided by GenMark Diagnostics
    Respiratory Virus
    Additional relevant MeSH terms:
    Respiratory Tract Infections

    Study Results

    No Results Posted as of Dec 28, 2015