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Completed

NCT Number: NCT06713642

SPOTFIRE Sore Throat (ST) Study

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.

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Key information

Conditions

Pharyngitis, Infective Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UW Health Urgent Care Centers

Madison, Wisconsin, 53717, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPOTFIRE ST System

Device

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

Other names: SPOTFIRE ST

Primary outcomes

  1. Aim 2 Clinical Outcome: Summary of Test Results

    Time frame: up to 20 minutes

    SPOTFIRE ST results by count.

  2. Aim 2 Clinical Outcome: Number of Participants With Follow up Testing

    Time frame: up to 3 weeks

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

  3. Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Flu vs SPOTFIRE Results

    Time frame: up to 3 weeks

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

  4. Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Respiratory Syncytial Virus (RSV) vs SPOTFIRE Results

    Time frame: up to 3 weeks

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

  5. Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: COVID PCR vs SPOTFIRE Results

    Time frame: up to 3 weeks

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

  6. Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Strep Antigen vs SPOTFIRE Results

    Time frame: up to 3 weeks

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

  7. Aim 2 Clinical Outcome: Summary of Resultant Prescriptions: Participants With Treatable Pathogens

    Time frame: 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)

  8. Aim 2 Clinical Outcome: Summary of Resultant Prescriptions: Participants With Viral Pathogens Prescribed Antibiotics

    Time frame: up to 3 weeks

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

  9. Aim 3: Participant Satisfaction Survey

    Time frame: 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.

  10. Aim 3: Participant Satisfaction Survey - How do the Results Feel?

    Time frame: 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.

  11. Aim 3: Participant Satisfaction Survey - Are You Satisfied With the Test Result?

    Time frame: 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.

  12. Aim 3: Participant Satisfaction Survey - Are You Satisfied With Provider Information?

    Time frame: 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.

  13. Aim 3: Participant Satisfaction Survey - Are You Satisfied With the Treatment?

    Time frame: 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.

  14. Aim 3: Participant Satisfaction Survey - How Useful is the Test in Understanding Your Illness?

    Time frame: 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.

  15. Aim 3: Participant Satisfaction Survey - Likelihood to do Test Again?

    Time frame: 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.

  16. Aim 3: Provider Utility Survey

    Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)

    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.

  17. Aim 3: Provider Satisfaction Survey - How Often Test Used?

    Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)

    Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.

  18. Aim 3: Provider Satisfaction Survey - Ease of Fitting Into Workflow?

    Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)

    Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.

  19. Aim 3: Provider Satisfaction Survey - How Prepared Did You Feel to Answer Questions About Test?

    Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)

    Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.

  20. Aim 3: Provider Satisfaction Survey -Test Differed From Initial Clinical Impression?

    Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)

    Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.

  21. Aim 3: Provider Satisfaction Survey - How Useful Was the Test?

    Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)

    Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.

  22. Aim 3: Provider Satisfaction Survey - To What Extent is This Panel Useful Over Having Just Rapid Antigen Tests (RAT) for Group A Strep (GAS)?

    Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)

    Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.

  23. Aim 3: Provider Satisfaction Survey - How Often do You Think This Test Helped You Rx Abx/AV More Judiciously?

    Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)

    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)

  24. Aim 3: Provider Satisfaction Survey - How Often do You Think You Would Use SPOTFIRE if Clinically Available All the Time?

    Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)

    Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.

  25. Aim 3: Provider Satisfaction Survey - When do You Think it Would be Best to Test Patients With SPOTFIRE?

    Time frame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)

    Provider Satisfaction will be measured using a self-report survey to indicate satisfaction with the testing experience.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • BioMérieux

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2024
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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