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QuickVue Influenza A+B Clinical Field Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00491283
First Posted: June 26, 2007
Last Update Posted: January 28, 2008
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.
Information provided by:
Quidel Corporation
  Purpose
A comparative study of different swab types used for collection of specimens for rapid inluenza testing

Condition Intervention
Influenza Device: Swab Specimen Collection (QuickVue)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Diagnostic
Official Title: Comparison of Swab Types for Specimen Collection

Resource links provided by NLM:


Further study details as provided by Quidel Corporation:

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

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

Study Start Date: July 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00491283     History of Changes
Other Study ID Numbers: CS-0119-08(B)
First Submitted: June 22, 2007
First Posted: June 26, 2007
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