SPOTFIRE Sore Throat (ST) Study

University of Wisconsin (UW)

Status: Completed

Conditions: Pharyngitis, Infective

Treatments: Device: SPOTFIRE ST System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06713642

BFD-RST-23-010 (Other Identifier)

2024-1569

Protocol Approved: 10/11/24 (Other Identifier)

A534265 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Eligible SPOTFIRE ST Participants

Experimental group

Description:

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.

Treatment:

Device: SPOTFIRE ST System