NCT06713642

SPOTFIRE Sore Throat (ST) Study

Completed NA Results posted Last updated 23 March 2026

What this trial tests

NA trial testing SPOTFIRE ST System in Pharyngitis, Infective in 200 participants. Completed in 31 March 2025.

Timeline

2 December 2024

Primary endpoint
31 March 2025

31 March 2025

Quick facts

Lead sponsor	University of Wisconsin, Madison
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	200
Start date	2 December 2024
Primary completion	31 March 2025
Estimated completion	31 March 2025
Sites	1 location across United States

Drugs / interventions tested

• SPOTFIRE ST System

Conditions studied

• Pharyngitis, Infective — all drugs for Pharyngitis, Infective →

Sponsor

University of Wisconsin, Madison

Who can join

1 and older, any sex, with Pharyngitis, Infective. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Aim 2 Clinical Outcome: Summary of Test Results Primary · up to 20 minutes

SPOTFIRE ST results by count.

Adenovirus

Group	Value	95% CI
Adult Detections	1
Pediatric Detections	6

Seasonal Coronavirus

Group	Value	95% CI
Adult Detections	14
Pediatric Detections	13

Human Metapneumovirus

Group	Value	95% CI
Adult Detections	2
Pediatric Detections	2

Rhino/Enterovirus

Group	Value	95% CI
Adult Detections	7
Pediatric Detections	21

Influenza A

Group	Value	95% CI
Adult Detections	14
Pediatric Detections	29

Influenza B

Group	Value	95% CI
Adult Detections	1
Pediatric Detections	9

Parainfluenza

Group	Value	95% CI
Adult Detections	1
Pediatric Detections	5

RSV

Group	Value	95% CI
Adult Detections	6
Pediatric Detections	11

Aim 2 Clinical Outcome: Number of Participants With Follow up Testing Primary · up to 3 weeks

Data collected via electronic medical record review 3 weeks post study visit.

Rapid Flu test

Group	Value	95% CI
Eligible SPOTFIRE ST Participants	16

Rapid RSV test

Group	Value	95% CI
Eligible SPOTFIRE ST Participants	16

COVID PCR test

Group	Value	95% CI
Eligible SPOTFIRE ST Participants	21

Rapid Strep Antigen test

Group	Value	95% CI
Eligible SPOTFIRE ST Participants	40

Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Flu vs SPOTFIRE Results Primary · up to 3 weeks

Data collected via electronic medical record review 3 weeks post study visit.

Group	Value	95% CI
Positive Rapid Flu Test	3
Negative Rapid Flu Test	0
Positive Rapid Flu Test	0
Negative Rapid Flu Test	13

Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Respiratory Syncytial Virus (RSV) vs SPOTFIRE Results Primary · up to 3 weeks

Data collected via electronic medical record review 3 weeks post study visit.

Group	Value	95% CI
Positive Rapid RSV Test	2
Negative Rapid RSV Test	0
Positive Rapid RSV Test	0
Negative Rapid RSV Test	14

Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: COVID PCR vs SPOTFIRE Results Primary · up to 3 weeks

Data collected via electronic medical record review 3 weeks post study visit.

Group	Value	95% CI
Positive COVID PCR Test	0
Negative COVID PCR Test	12
Positive COVID PCR Test	3
Negative COVID PCR Test	6

Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Strep Antigen vs SPOTFIRE Results Primary · up to 3 weeks

Data collected via electronic medical record review 3 weeks post study visit.

Group	Value	95% CI
Positive Rapid Strep Antigen Test	9
Negative Rapid Strep Antigen Test	3
Positive Rapid Strep Antigen Test	0
Negative Rapid Strep Antigen Test	28

Aim 2 Clinical Outcome: Summary of Resultant Prescriptions: Participants With Treatable Pathogens Primary · up to 3 weeks

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)

Treatable (FluA/B, GAS, Mpn, Cpn)

Group	Value	95% CI
Adult Detections	23
Pediatric Detections	80

Influenza detected and prescribed antiviral

Group	Value	95% CI
Adult Detections	6
Pediatric Detections	11

Treatable bacterial pathogen detection and prescribed antibiotic (GAS, Mpn, Cpn)

Group	Value	95% CI
Adult Detections	9
Pediatric Detections	49

Aim 2 Clinical Outcome: Summary of Resultant Prescriptions: Participants With Viral Pathogens Prescribed Antibiotics Primary · up to 3 weeks

SPOTFIRE ST resultant prescriptions by count. Data collected via electronic medical record review 3 weeks post study visit.

Patients without treatable bacterial detection prescribed an antibiotic

Group	Value	95% CI
Adult Detections	10
Pediatric Detections	10

SPOTFIRE negative

Group	Value	95% CI
Adult Detections	7
Pediatric Detections	6

SPOTFIRE single virus

Group	Value	95% CI
Adult Detections	2
Pediatric Detections	2

SPOTFIRE multiple viruses

Group	Value	95% CI
Adult Detections	0
Pediatric Detections	2

Aim 3: Participant Satisfaction Survey Primary · emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to approximately 4 months)

Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.

Completed Survey

Group	Value	95% CI
Eligible SPOTFIRE ST Participants	186

Swab Acceptable

Group	Value	95% CI
Eligible SPOTFIRE ST Participants	177

Took Test before Visit

Group	Value	95% CI
Eligible SPOTFIRE ST Participants	138

Liked Testing before Visit

Group	Value	95% CI
Eligible SPOTFIRE ST Participants	121

Aim 3: Participant Satisfaction Survey - How do the Results Feel? Primary · emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)

Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.

Group	Value	95% CI
Eligible SPOTFIRE ST Participants	74
Eligible SPOTFIRE ST Participants	82
Eligible SPOTFIRE ST Participants	20
Eligible SPOTFIRE ST Participants	7

Aim 3: Participant Satisfaction Survey - Are You Satisfied With the Test Result? Primary · emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)

Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.

Group	Value	95% CI
Eligible SPOTFIRE ST Participants	104
Eligible SPOTFIRE ST Participants	67
Eligible SPOTFIRE ST Participants	9
Eligible SPOTFIRE ST Participants	3

Aim 3: Participant Satisfaction Survey - Are You Satisfied With Provider Information? Primary · emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)

Participant Satisfaction will be measured using a self-report survey for satisfaction with the testing experience.

Group	Value	95% CI
Eligible SPOTFIRE ST Participants	103
Eligible SPOTFIRE ST Participants	62
Eligible SPOTFIRE ST Participants	14
Eligible SPOTFIRE ST Participants	7

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.