Back to resultsQuickVue Influenza A+B Clinical Field Trial
Primary Purpose
Influenza
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Swab Specimen Collection (QuickVue)
Sponsored by
About this trial
This is an interventional diagnostic trial for Influenza
Eligibility 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.
Sites / Locations
- Sydney Airport Medical Centre
Outcomes
Primary Outcome Measures
Sensitivity and Specificity
Secondary Outcome Measures
Sensitivity and Specificity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00491283
Brief Title
QuickVue Influenza A+B Clinical Field Trial
Official Title
Comparison of Swab Types for Specimen Collection
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Quidel Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A comparative study of different swab types used for collection of specimens for rapid inluenza testing
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Swab Specimen Collection (QuickVue)
Primary Outcome Measure Information:
Title
Sensitivity and Specificity
Time Frame
five months
Secondary Outcome Measure Information:
Title
Sensitivity and Specificity
Time Frame
Positive and Negative Predictive Values
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Keller, MD
Organizational Affiliation
Sydney Airport medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sydney Airport Medical Centre
City
Mascot
State/Province
New South Wales
ZIP/Postal Code
2020
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
QuickVue Influenza A+B Clinical Field Trial
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