Pilot Study of Strepic® Device for the Diagnosis of Group A Streptococcal Pharyngitis
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 7 - 64 |
| Updated: | 3/15/2019 |
| Start Date: | January 2, 2019 |
| End Date: | August 30, 2019 |
| Contact: | Anusha Krishnadasan, PhD |
| Email: | idnet@ucla.edu |
| Phone: | 310-592-4364 |
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.
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.
Inclusion Criteria:
1. All patients aged 7-64 years of age with suspected GAS pharyngitis with modified
Centor (McIsaac) score ≥2; and
2. Patient agrees to participate in study and patient or parent/guardian sign
consent/assent form.
Exclusion Criteria:
1. Pharyngeal swab performed immediately prior to study team approach;
2. Prior enrollment in this study;
3. Pharyngeal symptoms >7 days;
4. Peritonsillar abscess;
5. Antibiotic use within one week of index visit;
6. Inability to open mouth to visualize the pharynx; and
7. Inability to understand English or Spanish, as study forms including consent and
assent forms will be written in English and Spanish;
8. Woman who is pregnant (self-reported, pregnancy test will not be performed) or
nursing;
9. 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).
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