N/A N=200 Diagnostic

SPOTFIRE Sore Throat (ST) Study

Pharyngitis, Infective

Bottom Line

View on ClinicalTrials.gov: NCT06713642 ↗

Enrolled (actual)

200

Serious AEs

0.0%

Results posted

Mar 2026

Primary outcome: Primary: Aim 2 Clinical Outcome: Summary of Test Results — 1; 6; 14; 13 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SPOTFIRE ST System (Device)
Age: Pediatric, Adult, Older Adult · 1+ yrs
Sex: All
Sponsor: University of Wisconsin, Madison
Primary completion: Mar 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Aim 2 Clinical Outcome: Summary of Test Results	1; 6; 14; 13; 2; 2	—
PRIMARY Aim 2 Clinical Outcome: Number of Participants With Follow up Testing	16; 16; 21; 40	—
PRIMARY Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Flu vs SPOTFIRE Results	3; 0; 0; 13	—
PRIMARY Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Respiratory Syncytial Virus (RSV) vs SPOTFIRE Results	2; 0; 0; 14	—
PRIMARY Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: COVID PCR vs SPOTFIRE Results	0; 12; 3; 6	—
PRIMARY Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Strep Antigen vs SPOTFIRE Results	9; 3; 0; 28	—
PRIMARY Aim 2 Clinical Outcome: Summary of Resultant Prescriptions: Participants With Treatable Pathogens	23; 80; 6; 11; 9; 49	—
PRIMARY Aim 2 Clinical Outcome: Summary of Resultant Prescriptions: Participants With Viral Pathogens Prescribed Antibiotics	10; 10; 7; 6; 2; 2	—
PRIMARY Aim 3: Participant Satisfaction Survey	186; 177; 138; 121	—
PRIMARY Aim 3: Participant Satisfaction Survey - How do the Results Feel?	74; 82; 20; 7; 3	—
PRIMARY Aim 3: Participant Satisfaction Survey - Are You Satisfied With the Test Result?	104; 67; 9; 3; 2	—
PRIMARY Aim 3: Participant Satisfaction Survey - Are You Satisfied With Provider Information?	103; 62; 14; 7; 0	—
PRIMARY Aim 3: Participant Satisfaction Survey - Are You Satisfied With the Treatment?	90; 72; 11; 8; 5	—
PRIMARY Aim 3: Participant Satisfaction Survey - How Useful is the Test in Understanding Your Illness?	128; 38; 12; 3; 5	—
PRIMARY Aim 3: Participant Satisfaction Survey - Likelihood to do Test Again?	132; 41; 7; 4; 1	—
PRIMARY Aim 3: Provider Utility Survey	5.51; 5.50; 4.69; 5.09; 2.46; 2.63	—
PRIMARY Aim 3: Provider Satisfaction Survey - How Often Test Used?	5; 13; 15; 23	—
PRIMARY Aim 3: Provider Satisfaction Survey - Ease of Fitting Into Workflow?	20; 7; 6; 0; 0	—
PRIMARY Aim 3: Provider Satisfaction Survey - How Prepared Did You Feel to Answer Questions About Test?	8; 13; 9; 2; 1	—
PRIMARY Aim 3: Provider Satisfaction Survey -Test Differed From Initial Clinical Impression?	2; 10; 11; 9	—
PRIMARY Aim 3: Provider Satisfaction Survey - How Useful Was the Test?	13; 11; 4; 3; 2	—
PRIMARY Aim 3: Provider Satisfaction Survey - To What Extent is This Panel Useful Over Having Just Rapid Antigen Tests (RAT) for Group A Strep (GAS)?	13; 11; 6; 2; 1	—
PRIMARY Aim 3: Provider Satisfaction Survey - How Often do You Think This Test Helped You Rx Abx/AV More Judiciously?	6; 8; 8; 8; 3	—
PRIMARY Aim 3: Provider Satisfaction Survey - How Often do You Think You Would Use SPOTFIRE if Clinically Available All the Time?	6; 20; 5; 2; 0	—
PRIMARY Aim 3: Provider Satisfaction Survey - When do You Think it Would be Best to Test Patients With SPOTFIRE?	27; 6; 0	—

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06713642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.