Strep A FIA Field Study, Sofia

Completed

Conditions studied: Group A Streptococcus

In brief

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

Key facts

Study ID: NCT02153008
Run by: Quidel Corporation
People needed: 1708
Starts: 2014-04-01
Expected to finish: 2016-07-01
Last updated by the study team: 2017-08-03

Who can join

Age: 3 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male and Female, 3 years of age or older
Must currently be exhibiting one or more of the symptoms characteristic of pharyngitis to be eligible for inclusion in this study.
For example:
Acute onset of sore throat
Redness of the posterior pharyngeal wall
Difficulty/pain on swallowing
Fever, > 37.8º C (100ºF) at presentation or within past 24 hours
Pharyngeal exudate
Tender cervical lymphadenopathy
Absence of cough, runny nose or other upper respiratory symptoms.*
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.

You may not qualify if…

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.

Where it is running

Best Medical Group, LLC — Phoenix, Arizona, United States
Gentle Medical Associates — Boynton Beach, Florida, United States
Pediatrics by the Sea — Delray Beach, Florida, United States
Teena Hughes, MD — Tampa, Florida, United States
Twelve Corners Pediatrics — Rochester, New York, United States
Veritas, PA — Belton, Texas, United States
Advanced Pediatrics — Vienna, Virginia, United States

Full record on ClinicalTrials.gov

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