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QuickVue Influenza A+B Clinical Field Trial

This study has been completed.
Sponsor:
Information provided by:
Quidel Corporation
ClinicalTrials.gov Identifier:
NCT00491283
First received: June 22, 2007
Last updated: January 23, 2008
Last verified: January 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: Comparison of Swab Types for Specimen Collection

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00491283     History of Changes
Other Study ID Numbers: CS-0119-08(B)
Study First Received: June 22, 2007
Last Updated: January 23, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013