SPOTFIRE Sore Throat (ST) Study

SPOTFIRE ST TITUS STUDY: Provider Identified Target Populations, Implementation, Test Performance, Potential Utility, and Satisfaction of SPOTFIRE ST in the Urgent Care

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.

Study Overview

• Status: Completed
• Conditions: Pharyngitis, Infective
• Intervention / Treatment: Device: SPOTFIRE ST System

Detailed 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 (preparatory for the clinical trial, included here for context only).

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53717
      • UW Health Urgent Care Centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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 informed consent/assent forms
• Refusal to provide their demographics, household information

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eligible SPOTFIRE ST Participants; A maximum of 200 patients, representing the top 3-4 patient groups that were identified as benefitting most from a SPOTFIRE ST test through the provider survey, presenting at the Urgent Care facilities, will be enrolled.	Device: SPOTFIRE ST System; Polymerase chain reaction (PCR) test that identifies up to 13 different viral and bacterial pathogens in about 20 Minutes; Other Names: SPOTFIRE ST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aim 2 Clinical Outcome: Summary of Test Results	SPOTFIRE ST results by count.	up to 20 minutes
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing	Data collected via electronic medical record review 3 weeks post study visit.	up to 3 weeks
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Flu vs SPOTFIRE Results	Data collected via electronic medical record review 3 weeks post study visit.	up to 3 weeks
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Respiratory Syncytial Virus (RSV) vs SPOTFIRE Results	Data collected via electronic medical record review 3 weeks post study visit.	up to 3 weeks
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: COVID PCR vs SPOTFIRE Results	Data collected via electronic medical record review 3 weeks post study visit.	up to 3 weeks
Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Strep Antigen vs SPOTFIRE Results	Data collected via electronic medical record review 3 weeks post study visit.	up to 3 weeks
Aim 2 Clinical Outcome: Summary of Resultant Prescriptions: Participants With Treatable Pathogens	SPOTFIRE ST resultant prescriptions by count. Data collected via electronic medical record review 3 weeks post study visit. Treatable Pathogens include: Influenza A or B (FluA/B), Group A Strep (GAS), Mycoplasma pneumoniae (Mpn), Chlamydia pneumoniae (Cpn)	up to 3 weeks
Aim 2 Clinical Outcome: Summary of Resultant Prescriptions: Participants With Viral Pathogens Prescribed Antibiotics	SPOTFIRE ST resultant prescriptions by count. Data collected via electronic medical record review 3 weeks post study visit.	up to 3 weeks
Aim 3: Participant Satisfaction Survey	Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.	emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to approximately 4 months)
Aim 3: Participant Satisfaction Survey - How do the Results Feel?	Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.	emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Participant Satisfaction Survey - Are You Satisfied With the Test Result?	Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.	emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Participant Satisfaction Survey - Are You Satisfied With Provider Information?	Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.	emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Participant Satisfaction Survey - Are You Satisfied With the Treatment?	Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.	emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Participant Satisfaction Survey - How Useful is the Test in Understanding Your Illness?	Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.	emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Participant Satisfaction Survey - Likelihood to do Test Again?	Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.	emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Utility Survey	Providers will be surveyed to learn how they might use the SPOTFIRE test in the future. Survey responses will be ranked and reported by response rate. Providers were asked to rank each patient population from 1-7, a nominal point value was given for this ranking to generate the scores (rank of 1=1, rank of 2=2, etc.) Lower scores indicate higher (more important) ranking. Mean rank score for each patient population is reported here to give the reader an idea of how important each item was for the group of providers.	emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Satisfaction Survey - How Often Test Used?	Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.	emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Satisfaction Survey - Ease of Fitting Into Workflow?	Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.	emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Satisfaction Survey - How Prepared Did You Feel to Answer Questions About Test?	Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.	emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Satisfaction Survey -Test Differed From Initial Clinical Impression?	Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.	emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Satisfaction Survey - How Useful Was the Test?	Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.	emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Satisfaction Survey - To What Extent is This Panel Useful Over Having Just Rapid Antigen Tests (RAT) for Group A Strep (GAS)?	Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.	emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Satisfaction Survey - How Often do You Think This Test Helped You Rx Abx/AV More Judiciously?	Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience. Prescription for Antibiotics or Antivirals (Rx Abx/AV)	emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Satisfaction Survey - How Often do You Think You Would Use SPOTFIRE if Clinically Available All the Time?	Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.	emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Aim 3: Provider Satisfaction Survey - When do You Think it Would be Best to Test Patients With SPOTFIRE?	Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.	emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: BioMérieux
• Investigators: Principal Investigator: Alexander Lepak, MD, UW School of Medicine and Public Health

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: November 27, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: diagnostic test
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Pharyngitis
• Other Study ID Numbers: 2024-1569; A534265 (Other Identifier: UW Madison); Protocol Approved: 10/11/24 (Other Identifier: UW Madison); BFD-RST-23-010 (Other Identifier: Sponsor Protocol ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes