Sofia Strep A FIA Field Study

Stopped early

Conditions studied: Group A Streptococcus, Strep Throat

In brief

The purpose of this study is to demonstrate the ability of the Sofia Strep A FIA test and Sofia Analyzer to accurately detect a throat swab specimen for the presence or absence of Group A Streptococcus when compared to culture.

Key facts

Study ID

NCT01494792

Run by

Quidel Corporation

People needed

2090

Starts

2011-11-01

Expected to finish

2012-08-01

Last updated by the study team

2012-10-10

Who can join

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

You may qualify if…

• Presence of sore throat
• Redness of the posterior pharyngeal wall
• Tonsillar exudate
• Tonsillar swelling
• Tender anterior cervical adenopathy
• Fever, > 38º C (100.4ºF) at presentation or within past 24 hours
• Other symptoms that may be present, in addition to above symptoms for GAS:
• Rash, typical of scarlet fever
• Abnormal tympanic membranes
• Palatal petechiae

You may not qualify if…

• Subjects treated with antibiotics currently or within the previous week (7 days) 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

• La Costa Pediatrics — Carlsbad, California, United States
• Santo Nino Medical Clinic — Panorama City, California, United States
• La Jolla Pediatrics — San Diego, California, United States
• Teena Hughes, MD — Tampa, Florida, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Twelve Corners Pediatrics — Rochester, New York, United States
• Montrose Family Practice — Akron, Ohio, United States
• Advanced Pediatrics — Vienna, Virginia, United States

Full record on ClinicalTrials.gov

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