Pharyngitis, Infective
Conditions
Keywords
diagnostic test
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.
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.
Interventions
DEVICESPOTFIRE ST System
Polymerase chain reaction (PCR) test that identifies up to 13 different viral and bacterial pathogens in about 20 Minutes
Sponsors
University of Wisconsin, Madison
BioMérieux
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aim 2 Clinical Outcome: Summary of Test Results | up to 20 minutes | SPOTFIRE ST results by count. |
| Aim 2 Clinical Outcome: Number of Participants With Follow up Testing | up to 3 weeks | Data collected via electronic medical record review 3 weeks post study visit. |
| Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Flu vs SPOTFIRE Results | up to 3 weeks | Data collected via electronic medical record review 3 weeks post study visit. |
| Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Respiratory Syncytial Virus (RSV) vs SPOTFIRE Results | up to 3 weeks | Data collected via electronic medical record review 3 weeks post study visit. |
| Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: COVID PCR vs SPOTFIRE Results | up to 3 weeks | Data collected via electronic medical record review 3 weeks post study visit. |
| Aim 2 Clinical Outcome: Number of Participants With Follow up Testing: Rapid Strep Antigen vs SPOTFIRE Results | up to 3 weeks | Data collected via electronic medical record review 3 weeks post study visit. |
| Aim 2 Clinical Outcome: Summary of Resultant Prescriptions: Participants With Treatable Pathogens | 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) |
| Aim 2 Clinical Outcome: Summary of Resultant Prescriptions: Participants With Viral Pathogens Prescribed Antibiotics | up to 3 weeks | SPOTFIRE ST resultant prescriptions by count. Data collected via electronic medical record review 3 weeks post study visit. |
| Aim 3: Participant Satisfaction Survey | 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. |
| Aim 3: Participant Satisfaction Survey - How do the Results Feel? | 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. |
| Aim 3: Participant Satisfaction Survey - Are You Satisfied With the Test Result? | 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. |
| Aim 3: Participant Satisfaction Survey - Are You Satisfied With Provider Information? | 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. |
| Aim 3: Participant Satisfaction Survey - Are You Satisfied With the Treatment? | 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. |
| Aim 3: Participant Satisfaction Survey - How Useful is the Test in Understanding Your Illness? | 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. |
| Aim 3: Participant Satisfaction Survey - Likelihood to do Test Again? | 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. |
| Aim 3: Provider Utility Survey | 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. |
| Aim 3: Provider Satisfaction Survey - How Often Test Used? | 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. |
| Aim 3: Provider Satisfaction Survey - Ease of Fitting Into Workflow? | 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. |
| Aim 3: Provider Satisfaction Survey - How Prepared Did You Feel to Answer Questions About Test? | 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. |
| Aim 3: Provider Satisfaction Survey -Test Differed From Initial Clinical Impression? | 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. |
| Aim 3: Provider Satisfaction Survey - How Useful Was the Test? | 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. |
| Aim 3: Provider Satisfaction Survey - To What Extent is This Panel Useful Over Having Just Rapid Antigen Tests (RAT) for Group A Strep (GAS)? | 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. |
| Aim 3: Provider Satisfaction Survey - How Often do You Think This Test Helped You Rx Abx/AV More Judiciously? | 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) |
| Aim 3: Provider Satisfaction Survey - How Often do You Think You Would Use SPOTFIRE if Clinically Available All the Time? | 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. |
| Aim 3: Provider Satisfaction Survey - When do You Think it Would be Best to Test Patients With SPOTFIRE? | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlexander Lepak, MD
UW School of Medicine and Public Health
Participant flow
Recruitment details
Participants were consented and enrolled from December 2024 to March 2025. Providers were not formally consented, their survey response was voluntary. Provider participation was preparatory to research only and was deemed Program Evaluation pursuant to 45 Code of Federal Regulations (CFR) 46.
Pre-assignment details
371 participants were screened for enrollment into the study, 232 were found eligible, and 200 enrolled. Most participants declined enrollment because they were not interested or feeling too sick to participate.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 24.8 years |
| Age Group Adult | 83 Participants |
| Age Group Pediatric | 117 Participants |
| Attend Daycare No | 173 Participants |
| Attend Daycare Unreported | 4 Participants |
| Attend Daycare Yes | 23 Participants |
| Attend School Home or Virtual | 4 Participants |
| Attend School In Person | 106 Participants |
| Attend School No | 90 Participants |
| Attend Work Hybrid (both remote / in person) | 21 Participants |
| Attend Work In Person | 49 Participants |
| Attend Work No | 122 Participants |
| Attend Work Remote or Virtual | 6 Participants |
| Attend Work Unreported | 2 Participants |
| Coronavirus (COVID) Vaccine within the last 12 months No | 103 Participants |
| Coronavirus (COVID) Vaccine within the last 12 months Unreported | 10 Participants |
| Coronavirus (COVID) Vaccine within the last 12 months Yes | 87 Participants |
| Days of Illness Prior to Presentation | 3.04 days STANDARD_DEVIATION 1.9 |
| Flu Vaccine (current year) No | 83 Participants |
| Flu Vaccine (current year) Unreported | 6 Participants |
| Flu Vaccine (current year) Yes | 111 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 Participants |
| Race/Ethnicity, Customized Asian | 19 Participants |
| Race/Ethnicity, Customized Black or African American | 17 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 4 Participants |
| Race/Ethnicity, Customized Prefer not to answer | 4 Participants |
| Race/Ethnicity, Customized White / Caucasian | 167 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 13 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 152 Participants |
| Recruitment Group Ages 12-35 months with fever | 7 Participants |
| Recruitment Group Ages 3-17 years with sore throat | 110 Participants |
| Recruitment Group Any age with comorbidities (ie. respiratory, cardiovascular, metabolic, renal) with sore throat | 98 Participants |
| Recruitment Group Any age with immunocompromising conditions or is on immunocompromising medications with sore throat | 20 Participants |
| Region of Enrollment United States | 200 participants |
| Reported Exposure to someone else ill No | 84 Participants |
| Reported Exposure to someone else ill Unsure | 80 Participants |
| Reported Exposure to someone else ill Yes | 36 Participants |
| Severity of Illness Mild | 39 Participants |
| Severity of Illness Moderate | 137 Participants |
| Severity of Illness Severe | 20 Participants |
| Severity of Illness Unreported | 4 Participants |
| Sex/Gender, Customized Female | 111 Participants |
| Sex/Gender, Customized Male | 86 Participants |
| Sex/Gender, Customized Non-Binary | 2 Participants |
| Sex/Gender, Customized Prefer Not to Answer | 1 Participants |
| Symptoms Abdominal Pain | 17 Participants |
| Symptoms Arthralgia | 15 Participants |
| Symptoms Chills | 68 Participants |
| Symptoms Conjunctivitis | 2 Participants |
| Symptoms Cough | 134 Participants |
| Symptoms Diarrhea | 9 Participants |
| Symptoms Ear Pain | 42 Participants |
| Symptoms Fever | 88 Participants |
| Symptoms Headache | 105 Participants |
| Symptoms Loss of Appetite | 48 Participants |
| Symptoms Loss of Smell | 7 Participants |
| Symptoms Loss of Taste | 7 Participants |
| Symptoms Malaise | 74 Participants |
| Symptoms Myalgia | 42 Participants |
| Symptoms Other | 16 Participants |
| Symptoms Rhinorrhea | 105 Participants |
| Symptoms Sinus Congestion | 102 Participants |
| Symptoms SOB | 28 Participants |
| Symptoms Sore Throat | 193 Participants |
| Symptoms Vomiting | 17 Participants |
| Symptoms Wheeze | 20 Participants |
| Tobacco No | 185 Participants |
| Tobacco Secondhand Exposure Only | 6 Participants |
| Tobacco Unreported | 3 Participants |
| Tobacco Yes | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 200 |
| other Total, other adverse events | 0 / 200 |
| serious Total, serious adverse events | 0 / 200 |
Outcome results
None listed