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

NCT03777098 | Completed

• 1 other identifier: 01-2018
• Study Type: observational
• Target: 426
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Group A Streptococcal Infection

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Strepic® Device 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.

Eligibility Criteria

• Age: 7 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• David A. Talan: lead
• Light AI, Inc.: collaborator

Study Sites (1)

Olive View-UCLA Medical Center

Sylmar, California, 91342, United States

Location

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Gregory Moran, MD

  Olive View-UCLA Education & Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-PI

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 17, 2018
• Study Start: January 2, 2019
• Primary Completion: November 30, 2021
• Study Completion: December 30, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)