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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03777098
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : March 13, 2020
Light AI, Inc.
Information provided by (Responsible Party):
David A. Talan, Olive View-UCLA Education & Research Institute

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.

Condition or disease Intervention/treatment
Group A Streptococcal Infection Device: Strepic® Device

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study of Strepic® Device for the Diagnosis of Group A Streptococcal Pharyngitis
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Intervention Details:
  • 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.

Primary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   7 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to participating U.S. emergency departments or clinics with complaint of pharyngitis will be screened.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03777098

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Contact: Anusha Krishnadasan, PhD 310-592-4364
Contact: David Talan, MD

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United States, California
Olive View-UCLA Medical Center Recruiting
Sylmar, California, United States, 91342
Contact: Gregory Moran, MD         
Sponsors and Collaborators
David A. Talan
Light AI, Inc.
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Principal Investigator: Gregory Moran, MD Olive View-UCLA Education & Research Institute
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Responsible Party: David A. Talan, Co-PI, Olive View-UCLA Education & Research Institute Identifier: NCT03777098    
Other Study ID Numbers: 01-2018
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Streptococcal Infections
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Gram-Positive Bacterial Infections
Bacterial Infections