In Vitro Diagnostic Device for the Detection of Strep A



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:3 - Any
Updated:5/3/2014
Start Date:December 2013
End Date:April 2014

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Trial Summary
Trial Overview
Inclusion Criteria

Multi-Center Study of an In Vitro Diagnostic Device for the Detection of Strep A

The purpose of this trial is to show the accuracy and specificity of the Liat analyzer and
assay for detecting Strep A at the point of care lab compared to culture.


Inclusion Criteria:

- Subjects who are 3 years of age or older

- Subjects exhibiting symptoms characteristic of pharyngitis, possibly Streptococcus A,
including:

- presence of sore throat, and at least one other symptom from the list below:

- redness of the posterior pharyngeal wall

- pharyngeal or tonsillar exudate

- tonsillar swelling

- tender cervical lymphadenopathy

- fever, >38C at presentation or within the past 24 hours

- Subjects who are able to understand and consent to participation; for minors under
the age of 18, this includes parent or legal guardian

Exclusion Criteria:

- Subjects treated with antibiotics currently or within the previous 7 days.
We found this trial at
5
sites
Norwich Pediatrics
Norwich, Connecticut 06360
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Norwich, CT
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Plano Pediatrics
Plano, Texas 75093
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mi
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Plano, TX
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Twelve Corners Pediatrics
Rochester, New York 14618
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Rochester, NY
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Meridian Clinical Research, LLC
Savannah, Georgia 31406
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mi
from
Savannah, GA
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Advanced Pediatrics
Vienna, Virginia 22180
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mi
from
Vienna, VA
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