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FebriDx® Pediatric Validation Study
Sponsor: Lumos Diagnostics
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.
Official title: FebriDx® Pediatric Validation Study Protocol
Key Details
Gender
All
Age Range
2 Years - 11 Years
Study Type
OBSERVATIONAL
Enrollment
800
Start Date
2025-10-09
Completion Date
2026-11-30
Last Updated
2025-10-31
Healthy Volunteers
No
Conditions
Interventions
FebriDx
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