Clinical trial NCT06713642: SPOTFIRE Sore Throat (ST) 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharyngitis, Infective
Keywords: diagnostic test
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: BioMérieux
First posted: 2024-12-03
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

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

Primary outcomes:
measure: Aim 2 Clinical Outcome: Summary of test results
timeFrame: up to 20 minutes
measure: Aim 2 Clinical Outcome: Number of Participants with follow up testing
timeFrame: up to 3 weeks
measure: Aim 2 Clinical Outcome: Summary of Resultant Prescriptions
timeFrame: up to 3 weeks
measure: Aim 3: Participant Satisfaction Survey
timeFrame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
measure: Aim 3: Provider Satisfaction Survey
timeFrame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
measure: Aim 3: Provider Utility Survey
timeFrame: emailed after SPOTFIRE testing, survey data collected from all participants through the end of the study (up to 4 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Health Urgent Care Centers
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: Alexander Lepak, MD
role: PRINCIPAL_INVESTIGATOR
References: