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QuickVue Influenza A+B Clinical Field Trial

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ClinicalTrials.gov Identifier: NCT00491283
Recruitment Status : Completed
First Posted : June 26, 2007
Last Update Posted : January 28, 2008
Sponsor:
Information provided by:
Quidel Corporation

Brief Summary:
A comparative study of different swab types used for collection of specimens for rapid inluenza testing

Condition or disease Intervention/treatment Phase
Influenza Device: Swab Specimen Collection (QuickVue) Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Diagnostic
Official Title: Comparison of Swab Types for Specimen Collection
Study Start Date : July 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources




Primary Outcome Measures :
  1. Sensitivity and Specificity [ Time Frame: five months ]

Secondary Outcome Measures :
  1. Sensitivity and Specificity [ Time Frame: Positive and Negative Predictive Values ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must have:

  • Fever (>38°C) (at time of visit or within the previous 48 hrs by history) and at least two of the following symptoms:

    • Chills/sweats
    • Cough
    • Dyspnea (labored, difficult breathing)
    • Fatigue
    • Headache
    • Myalgia (deep muscle aches)
    • Nasal congestion
    • Runny nose
    • Sore throat

Exclusion Criteria:

  • Patients who are undergoing treatment with antivirals, now or within the last 7 days cannot be included in this study.

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): NCT00491283


Locations
Australia, New South Wales
Sydney Airport Medical Centre
Mascot, New South Wales, Australia, 2020
Sponsors and Collaborators
Quidel Corporation
Investigators
Principal Investigator: Andrew Keller, MD Sydney Airport medical Centre

ClinicalTrials.gov Identifier: NCT00491283     History of Changes
Other Study ID Numbers: CS-0119-08(B)
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: January 28, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases