Status:
COMPLETED
Strep A Fluorescent Immunoassay and Analyzer Field Study
Lead Sponsor:
Quidel Corporation
Conditions:
Strep Throat
Eligibility:
All Genders
3+ years
Brief Summary
The purpose of this study is to demonstrate the ability of the Strep A Fluorescent Immunoassay Analyzer to accurately detect a throat swab specimen for the presence or absence of Strep A when compared...
Eligibility Criteria
Inclusion
- Male and female subjects three (3) years of age or older
- Must currently be exhibiting one or more of the following symptoms characteristic of pharyngitis
- Extreme sore throat
- Redness of the posterior pharyngeal wall
- Difficulty Swallowing
- Fever, \>38.7C (100F) at presentation or within past 24 hours
- Pharyngeal exudate
- Tender cervical lymphadenopathy
- Absence of cough or other upper respiratory symptoms
Exclusion
- Subjects currently under treatment with antibiotics are not to be included in this study.
- At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
1282 Patients enrolled
Trial Details
Trial ID
NCT01441479
Start Date
June 1 2011
End Date
December 1 2012
Last Update
February 7 2013
Active Locations (7)
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1
Best Medical Group
Phoenix, Arizona, United States, 85042
2
La Costa Pediatrics
Carlsbad, California, United States, 92009
3
La Jolla Pediatrics
San Diego, California, United States, 92121
4
Teena Hughes
Tampa, Florida, United States, 33613