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OpenTrials
Completed

NCT Number: NCT03777098

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.

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Key information

Age range

7 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Olive View-UCLA Medical Center

Sylmar, California, 91342, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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).

Treatment and study plan

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.

Primary outcomes

  1. Strepic Device Image

    Time frame: Day 1

    A picture of the participant's throat will be obtained at enrollment.

  2. Throat culture or PCR result

    Time frame: Day 2

    The results of throat culture or PCR (depending on the site) will be recorded and compared to the Strepic Device image findings

Sponsors and collaborators

Lead sponsor

David A. Talan

Other

Collaborators

  • Light AI Inc.

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 17, 2018
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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