Influenza Clinical Trial
Official title:
"Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study"
Verified date | May 2011 |
Source | Quidel Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
The objective of this study is to demonstrate the clinical performance of the Quidel Reader Influenza A+B test and Quidel Reader with the following sample types: nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash. Clinical performance will be based on comparison of Quidel Reader Influenza A+B results to cell culture at a Central Reference or Alternative Laboratory.
Status | Completed |
Enrollment | 2500 |
Est. completion date | April 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. Male or Female, of all ages (assuming appropriate consent is obtained). 2. Must currently be exhibiting symptoms characteristic of influenza-like-illness (ILI). For example: 1. Fever, = 38º C (100º F), either at the time of the visit or onset within the past two (2) days. 2. Nasal congestion 3. Rhinorrhea 4. Sore throat 5. Cough 6. Headache 7. Myalgia 8. Malaise Exclusion Criteria: 1. Has undergone treatment with anti-influenza antivirals within the previous 7 days, including, for example, one or more of the following, but not be limited to Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir or any other antiviral currently available in these classes. 2. Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days. 3. Unable to understand and consent to participation; for minors this includes parent or legal guardian. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Montrose Family Practice | Akron | Ohio |
United States | Dell's Children's Medical Center | Austin | Texas |
United States | La Costa Pediatrics | Carlsbad | California |
United States | Kamakshi Neelkantan, MD | Edgewood | Maryland |
United States | Robert Farron, DO | Far Rockaway | New York |
United States | Paul Janson, MD | Florence | Kentucky |
United States | Priority Care Pediatrics | Kansas City | Missouri |
United States | Adriana Castro, MD | Miami | Florida |
United States | Paul McLaughlin, MD | Mt. Sterling | Kentucky |
United States | DuPage Family Medicine | Naperville | Illinois |
United States | Norristown Family Physicians | Norristown | Pennsylvania |
United States | Complete Family Care | Northglenn | Colorado |
United States | Santo Nino Medical Clinic | Panorama City | California |
United States | Twelve Corners Pediatrics | Rochester | New York |
United States | La Jolla Pediatrics | San Diego | California |
United States | Teena Hughes, MD | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Quidel Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnosis of infection with influenza | Accurate diagnosis of infection with influenza A or influenza B confirmed by culture | 15 minutes | No |
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