RecruitingNCT07211997

FebriDx® Pediatric Validation Study

FebriDx® Pediatric Validation Study Protocol

Sponsor

Lumos Diagnostics

Enrollment

800 participants

Start Date

Oct 9, 2025

Study Type

OBSERVATIONAL

Conditions

Acute Respiratory Infections (ARIs)

Summary

The primary objective of this study is to determine performance characteristics of the FebriDx® test in differentiating bacterial from non-bacterial etiology among febrile pediatric patients (2-11 years) presenting to the emergency department, urgent care center or primary care office with a suspected acute respiratory tract infection.

Eligibility

Min Age: 2 YearsMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called FebriDx for people with acute respiratory infections (aris). The study is currently recruiting participants at 10 locations. People eligible for this study include aged 2 Years to 11 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFebriDx

Bacterial/Non-Bacterial Point-of-Care Assay that detects the presence of MxA and CRP in fingerstick blood

Locations(10)

Avacare

Colton, California, United States

PAS Research- Myrtle Avenue Pediatrics, Inc

Clearwater, Florida, United States

PAS Research- Sandhill Pediatrics PA

Lutz, Florida, United States

PAS Research

Tampa, Florida, United States

Hometown Urgent Care

Huber Heights, Ohio, United States

Hometown Urgent Care

Springfield, Ohio, United States

PAS Research

Pittsburgh, Pennsylvania, United States

Tribe

Charleston, South Carolina, United States

Tribe- Parkside Pediatrics

Greenville, South Carolina, United States

PAS Research

Edinburg, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07211997

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