SPOTFIRE Sore Throat (ST) Study

Last updated: April 15, 2025
Sponsor: University of Wisconsin, Madison
Overall Status: Completed

Phase

N/A

Condition

Pharyngitis

Treatment

SPOTFIRE ST System

Clinical Study ID

NCT06713642
2024-1569
A534265
BFD-RST-23-010
Protocol Approved: 10/11/24
  • Ages > 1
  • All Genders

Study Summary

The purpose of this study is to evaluate where urgent care (UC) clinicians see the most benefit for a novel, point of care pharyngitis test, SPOTFIRE ST, and describe its performance, potential clinical utility, and satisfaction of providers and patients with this novel test. Up to 200 participants will be on study for up to approximately 25 minutes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Illness onset in the last 7 days, AND:

  • Ages 1-2 (12-35 months old) with fever or

  • Ages 3-17 with sore throat or

  • Any age with immunocompromising conditions or is on immunocompromisingmedications with sore throat or

  • Any age with comorbidities (e.g., respiratory, cardiovascular, metabolic,renal, etc.) with sore throat

Exclusion

Exclusion Criteria:

  • Anatomic anomalies that would prohibit safely collecting a pharyngeal swab specimen

  • Symptom onset more than 7 days prior to arrival at urgent care

  • Patient is already on an antiviral medication or an antibiotic medication

  • Previous participation in the study

  • Unable to read and understand or refusal to sign the appropriate informedconsent/assent forms

  • Refusal to provide their demographics, household information

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: SPOTFIRE ST System
Phase:
Study Start date:
December 02, 2024
Estimated Completion Date:
March 31, 2025

Study Description

The broader study is separated into three specific aims.

AIM 1. Evaluate which specific patient populations UC providers see the most need and benefit from SPOTFIRE ST, a multiplex point of care pharyngitis test.

AIM 2. Evaluate the performance and effects of test results associated with important clinical outcomes (e.g., prescriptions, additional testing, disposition and follow-up) for patients in the top 3-4 high-risk subpopulations identified by providers in Specific AIM 1.

AIM 3. Evaluate patient and provider satisfaction and future use opportunities of the SPOTFIRE ST Panel testing platform in the clinical pathway for evaluating patients with pharyngitis in UC centers.

AIMS 2-3 are registered to this ClinicalTrials.gov record.

Connect with a study center

  • UW Health Urgent Care Centers

    Madison, Wisconsin 53717
    United States

    Site Not Available

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