Strep A FIA Field Study, Sofia



Status:Recruiting
Healthy:No
Age Range:3 - Any
Updated:4/21/2016
Start Date:April 2014
End Date:November 2015

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Sofia Strep A FIA Field Study

To demonstrate the clinical performance of the Strep A FIA and Sofia, using throat swabs
collected from symptomatic subjects.


Inclusion Criteria:

1. Male and Female, 3 years of age or older

2. Must currently be exhibiting one or more of the symptoms characteristic of
pharyngitis to be eligible for inclusion in this study.

For example:

1. Acute onset of sore throat

2. Redness of the posterior pharyngeal wall

3. Difficulty/pain on swallowing

4. Fever, > 37.8º C (100ºF) at presentation or within past 24 hours

5. Pharyngeal exudate

6. Tender cervical lymphadenopathy

7. Absence of cough, runny nose or other upper respiratory symptoms.*

8. Other, symptoms specific to Strep A not listed above.

- Must include at least one additional symptom from a-f and cannot be the only
criteria used to meet inclusion for enrollment in the study.

Exclusion Criteria:

1. Subjects currently under treatment with antibiotics are not to be included in this
study.

2. At clinical sites requiring informed consent, unable to understand and consent to
participation; for minors this includes parent or legal guardian.
We found this trial at
7
sites
Vienna, Virginia 22180
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Belton, Texas 76513
Principal Investigator: Aleta Bonner, MD
Phone: 254-624-3398
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Belton, TX
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Boynton Beach, Florida 33435
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Boynton Beach, FL
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Delray Beach, Florida 33483
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Delray Beach, FL
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Phoenix, Arizona 85042
Principal Investigator: Angel Gomez, MD
Phone: 602-824-4200
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Phoenix, AZ
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Rochester, New York 14618
Principal Investigator: Barbara Frelinger, MD
Phone: 585-473-3535
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Rochester, NY
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Tampa, Florida 33613
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Tampa, FL
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