Strep A Fluorescent Immunoassay and Analyzer Field Study
1 other identifier
observational
1,282
1 country
7
Brief Summary
The purpose of this study is to demonstrate the ability of the Strep A Fluorescent Immunoassay Analyzer to accurately detect a throat swab specimen for the presence or absence of Strep A when compared to culture.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2011
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 23, 2011
CompletedFirst Posted
Study publicly available on registry
September 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFebruary 7, 2013
December 1, 2012
1.5 years
September 23, 2011
February 5, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Streptococcus Group B identification
The purpose of this study was to identify via immunofluorescence technology, Group A Streptococcus, which was successfully done.
Immediate
Interventions
Eligibility Criteria
Subjects must be greater than 3 years of age and exhibiting symptoms characteristic of pharyngitis, possibly Group A Streptococcus.
You may qualify if:
- Male and female subjects three (3) years of age or older
- Must currently be exhibiting one or more of the following symptoms characteristic of pharyngitis
- Extreme sore throat
- Redness of the posterior pharyngeal wall
- Difficulty Swallowing
- Fever, \>38.7C (100F) at presentation or within past 24 hours
- Pharyngeal exudate
- Tender cervical lymphadenopathy
- Absence of cough or other upper respiratory symptoms
You may not qualify if:
- Subjects currently under treatment with antibiotics 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Best Medical Group
Phoenix, Arizona, 85042, United States
La Costa Pediatrics
Carlsbad, California, 92009, United States
La Jolla Pediatrics
San Diego, California, 92121, United States
Teena Hughes
Tampa, Florida, 33613, United States
FastER Urgent Care
Morris Plains, New Jersey, 07950, United States
Twelve Corners Pediatrics
Rochester, New York, 14618, United States
Advanced Pediatrics
Vienna, Virginia, 22180, United States
MeSH Terms
Interventions
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2011
First Posted
September 27, 2011
Study Start
June 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
February 7, 2013
Record last verified: 2012-12