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

Group A Streptococcal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03777098
• Other study ID #: 01-2018
• Status: Completed
• Start date: January 2, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2022
• Source: Olive View-UCLA Education & Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: December 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 64 Years

Eligibility

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).

Related Conditions & MeSH terms

• Group A Streptococcal Infection
• Pharyngitis
• Streptococcal Infections

Intervention

Device:
• Strepic® 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.

Locations

Country	Name	City	State
United States	Olive View-UCLA Medical Center	Sylmar	California

Sponsors (2)

Lead Sponsor	Collaborator
David A. Talan	Light AI, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Strepic Device Image	A picture of the participant's throat will be obtained at enrollment.	Day 1
Primary	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