CompletedNot Applicable

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

United States426 participantsStarted 2019-01-02

Plain-language summary

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.

Who can participate

Age range7 Years – 64 Years

SexALL

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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;

What they're measuring

Strepic Device Image

Timeframe: Day 1

Throat culture or PCR result

Timeframe: Day 2

Trial details

NCT IDNCT03777098

SponsorDavid A. Talan

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-11-30

View on ClinicalTrials.gov More Group A Streptococcal Infection trials