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
  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:


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
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, see Learn About Clinical Studies.

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 September 11, 2014