SPOTFIRE Sore Throat (ST) Study

NCT06713642 | Completed Results FDA Device

• 4 other identifiers: 2024-1569Protocol Approved: 10/11/24A534265BFD-RST-23-010
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pharyngitis, Infective

Keywords

diagnostic test

Outcome Measures

Primary Outcomes (25)

• 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)

Study Arms (1)

Eligible SPOTFIRE ST Participants

EXPERIMENTAL

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

Interventions

SPOTFIRE ST System DEVICE

Polymerase chain reaction (PCR) test that identifies up to 13 different viral and bacterial pathogens in about 20 Minutes

Also known as: SPOTFIRE ST

Eligible SPOTFIRE ST Participants

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioMérieux: collaborator
• University of Wisconsin, Madison: lead

Study Sites (1)

UW Health Urgent Care Centers

Madison, Wisconsin, 53717, United States

Location

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Alexander Lepak, MD, FIDSA
• Organization: University of Wisconsin School of Medicine and Public Health

ajlepak@medicine.wisc.edu

(608) 263-1545

Study Officials

• Alexander Lepak, MD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 3, 2024
• Study Start: December 2, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: March 23, 2026
• Results First Posted: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)