In Vitro Diagnostic Device for the Detection of Strep A

Completed

Conditions studied: Streptococcal Sore Throat

In brief

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.

Key facts

Study ID

NCT02068469

Run by

IQuum, Inc.

People needed

799

Starts

2013-12-01

Expected to finish

2014-04-01

Last updated by the study team

2016-08-31

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• Subjects treated with antibiotics currently or within the previous 7 days.

Where it is running

• Norwich Pediatrics — Norwich, Connecticut, United States
• Meridian Clinical Research — Savannah, Georgia, United States
• Twelve Corners Pediatrics — Rochester, New York, United States
• Plano Pediatrics — Plano, Texas, United States
• Advanced Pediatrics — Vienna, Virginia, United States

Full record on ClinicalTrials.gov

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