Pilot Study of Strepic® Device for the Diagnosis of Group A Streptococcal Pharyngitis

Study Overview
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Brief Summary
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The objective of this pilot study is to acquire images using the Strepic® device, a clinical prototype that has been designed specifically as a viable, low-cost, commercially realizable autofluorescence-based diagnostic test, using (1) fluorescence and (2) white light image data, as well as other clinical data points. By acquiring and analyzing the images of pharyngeal bacterial fluorescence and white light patterns in patients with Group A Streptococcus (GAS)-associated pharyngitis and comparing them with those observed in non-GAS pharyngitis, it is believed an algorithm can be developed such that the device will improve the ability of clinicians to quickly and accurately identify GAS infections.

Official Title
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Pilot Study of Strepic® Device for the Diagnosis of Group A Streptococcal Pharyngitis

Conditions
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Group A Streptococcal Infection

Intervention / Treatment
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* Device: Strepic® Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients aged 7-64 years of age with suspected GAS pharyngitis with modified Centor (McIsaac) score ≥2; and Patient agrees to participate in study and patient or parent/guardian sign consent/assent form. Exclusion Criteria: Pharyngeal swab performed immediately prior to study team approach; Prior enrollment in this study; Pharyngeal symptoms >7 days; Peritonsillar abscess; Antibiotic use within one week of index visit; Inability to open mouth to visualize the pharynx; and Inability to understand English or Spanish, as study forms including consent and assent forms will be written in English and Spanish; Woman who is pregnant (self-reported, pregnancy test will not be performed) or nursing; Current prisoner (define as an individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution).

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Strepic® Device|The Strepic® device is a qualitative point-of-care diagnostic test for the detection of GAS pharyngitis. The test uses direct visualization of the pharynx with a light source of specified wavelengths, causing excitation of endogenous fluorophores that emit a characteristic colored light pattern. White light images may give additional diagnostic accuracy through use of an artificial intelligence analysis of a large set of images of GAS and non-GAS pharyngitis.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strepic Device Image | A picture of the participant's throat will be obtained at enrollment. | Day 1 | 
| Throat culture or PCR result | The results of throat culture or PCR (depending on the site) will be recorded and compared to the Strepic Device image findings | Day 2 |