SPOTFIRE Sore Throat (ST) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-02

Study Completion Date

2025-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pharyngitis, Infective

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Eligible SPOTFIRE ST Participants

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.

Group Type EXPERIMENTAL

SPOTFIRE ST System

Intervention Type DEVICE

Polymerase chain reaction (PCR) test that identifies up to 13 different viral and bacterial pathogens in about 20 Minutes

Interventions

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SPOTFIRE ST System

Polymerase chain reaction (PCR) test that identifies up to 13 different viral and bacterial pathogens in about 20 Minutes

Intervention Type DEVICE

Other Intervention Names

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SPOTFIRE ST

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No