In Vitro Diagnostic Device for the Detection of Strep A
Completed
- Conditions
- Streptococcal Sore Throat
- Registration Number
- NCT02068469
- Lead Sponsor
- IQuum, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 799
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate sensitivity and specificity of the Liat Strep A assay when compared to culture Results based on samples collected at initial visit
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Twelve Corners Pediatrics
🇺🇸Rochester, New York, United States
Plano Pediatrics
🇺🇸Plano, Texas, United States
Advanced Pediatrics
🇺🇸Vienna, Virginia, United States
Meridian Clinical Research
🇺🇸Savannah, Georgia, United States
Norwich Pediatrics
🇺🇸Norwich, Connecticut, United States