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

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.

Study Overview

• Status: Completed
• Conditions: Group A Streptococcal Infection
• Intervention / Treatment: Device: Strepic® Device

• Study Type: Observational
• Enrollment (Actual): 426

Contacts and Locations

Study Locations

• United States
  • California
    • Sylmar, California, United States, 91342
      • Olive View-UCLA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 64 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to participating U.S. emergency departments or clinics with complaint of pharyngitis will be screened.

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: David A. Talan
• Collaborators: Light AI, Inc.
• Investigators: Principal Investigator: Gregory Moran, MD, Olive View-UCLA Education & Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2019
• Primary Completion (ACTUAL): November 30, 2021
• Study Completion (ACTUAL): December 30, 2021

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: December 12, 2018
• First Posted (ACTUAL): December 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Pharyngitis; Streptococcal Infections
• Other Study ID Numbers: 01-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No