Pharyngitis, InfectiveNCT06713642
SPOTFIRE Sore Throat (ST) Study
A study testing SPOTFIRE ST System in people with Pharyngitis, Infective, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Pharyngitis, Infective
- What is being tested?
- SPOTFIRE ST System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Health Urgent Care Centers
Madison, Wisconsin, 53717
About this study
Official title: SPOTFIRE ST TITUS STUDY: Provider Identified Target Populations, Implementation, Test Performance, Potential Utility, and Satisfaction of SPOTFIRE ST in the Urgent Care
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.
Read the 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.
- Conditions
- Pharyngitis, Infective
- Being tested
- SPOTFIRE ST System
- Keywords
- diagnostic test
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPOTFIRE ST SystemDevice
Also called SPOTFIRE ST
Polymerase chain reaction (PCR) test that identifies up to 13 different viral and bacterial pathogens in about 20 Minutes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SPOTFIRE ST System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 2 Clinical Outcome: Summary of Test Results
SPOTFIRE ST results by count.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start2 Dec 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pharyngitis, InfectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- BioMérieux
- Responsible party
- Sponsor
- Investigators
- Alexander Lepak, MD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713642
- Sponsor's protocol ID
- 2024-1569
- Other IDs
- Protocol Approved: 10/11/24, A534265, BFD-RST-23-010
- Status last verified
- Mar 2026
- First submitted
- 27 Nov 2024
- Last updated
- 23 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lepak AJ, Lehrer BJ, Barlow S, Goss M, Hamer C, He C, Norton D, Temte E, Walters S, Temte JL. Point-of-Care Multiplex NAAT for Acute Pharyngitis in the Urgent Care: Detection Patterns, Associated Antimicrobial Prescribing, and Stakeholder Perceptions. Open Forum Infect Dis. 2026 Jul 22;13(7):ofag441. doi: 10.1093/ofid/ofag441. eCollection 2026 Jul.
PubMed 42534379
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPOTFIRE ST TITUS STUDY: Provider Identified Target Populations, Implementation, Test Performance, Potential Utility, and Satisfaction of SPOTFIRE ST in the Urgent Care
- ClinicalTrials.gov ID
- NCT06713642
- Acronym / sponsor ID
- 2024-1569
- Conditions
- Pharyngitis, Infective
- Keywords
- diagnostic test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- BioMérieux
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 3 Dec 2024 (actual)
- Results
- Posted 23 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible SPOTFIRE ST Participants | Experimental | Device: SPOTFIRE ST SystemA 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. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Illness onset in the last 7 days, AND:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPOTFIRE ST SystemAlso: SPOTFIRE STPolymerase chain reaction (PCR) test that identifies up to 13 different viral and bacterial pathogens in about 20 Minutes | Device | Eligible SPOTFIRE ST Participants |
Primary outcome
Aim 2 Clinical Outcome: Summary of Test Results
Time frame: up to 20 minutes
SPOTFIRE ST results by count.
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.
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.
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.
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.
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.
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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)
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42534379Lepak AJ, Lehrer BJ, Barlow S, Goss M, Hamer C, He C, Norton D, Temte E, Walters S, Temte JL. Point-of-Care Multiplex NAAT for Acute Pharyngitis in the Urgent Care: Detection Patterns, Associated Antimicrobial Prescribing, and Stakeholder Perceptions. Open Forum Infect Dis. 2026 Jul 22;13(7):ofag441. doi: 10.1093/ofid/ofag441. eCollection 2026 Jul.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Lepak, MD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPOTFIRE ST System in people with Pharyngitis, Infective, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 2 Clinical Outcome: Summary of Test Results (time frame: up to 20 minutes). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06713642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.