NCT06713642

SPOTFIRE Sore Throat (ST) Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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.

Conditions

• Pharyngitis, Infective

Interventions

Type	Name	Description
DEVICE	SPOTFIRE ST System	Polymerase chain reaction (PCR) test that identifies up to 13 different viral and bacterial pathogens in about 20 Minutes

Timeline

• Start date: 2024-12-02
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2024-12-03
• Last updated: 2026-03-23
• Results posted: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study