Status:
COMPLETED
Pilot Study of Strepic® Device for the Diagnosis of Group A Streptococcal Pharyngitis
Lead Sponsor:
David A. Talan
Collaborating Sponsors:
Light AI, Inc.
Conditions:
Group A Streptococcal Infection
Eligibility:
All Genders
7-64 years
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 autofluorescen...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
426 Patients enrolled
Trial Details
Trial ID
NCT03777098
Start Date
January 2 2019
End Date
December 30 2021
Last Update
April 20 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Olive View-UCLA Medical Center
Sylmar, California, United States, 91342