Status:
TERMINATED
Sofia Strep A FIA Field Study
Lead Sponsor:
Quidel Corporation
Conditions:
Group A Streptococcus
Strep Throat
Eligibility:
All Genders
3+ years
Brief Summary
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 Streptococcu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
2090 Patients enrolled
Trial Details
Trial ID
NCT01494792
Start Date
November 1 2011
End Date
August 1 2012
Last Update
October 10 2012
Active Locations (8)
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1
La Costa Pediatrics
Carlsbad, California, United States, 92009
2
Santo Nino Medical Clinic
Panorama City, California, United States, 91402
3
La Jolla Pediatrics
San Diego, California, United States, 92121
4
Teena Hughes, MD
Tampa, Florida, United States, 33613