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

David A. Talan

Status: Completed

Conditions: Group A Streptococcal Infection

Treatments: Device: Strepic® Device

Study type: Observational

Funder types: Other

Identifiers

NCT03777098

01-2018

Details and patient eligibility

About

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.

Enrollment: 426 patients

Sex: All

Ages: 7 to 64 years old

Volunteers: No Healthy Volunteers

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).