FebriDx® Pediatric Validation Study

Recruiting now

Conditions studied: Acute Respiratory Infections (ARIs)

In brief

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.

Key facts

Study ID

NCT07211997

Run by

Lumos Diagnostics

People needed

800

Starts

2025-10-09

Expected to finish

2027-05-30

Last updated by the study team

2026-07-07

Who can join

Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent by parent/guardian and Assent for ages 7-11 years
• Exhibit or report of a new onset measured temperature (oral or tympanic) of greater than or equal to 100.4°F/38°C within 3 days (72 hours) of enrollment
• Clinical suspicion for Acute Respiratory Infection beginning within 7 days before enrollment AND presents with at least one of the following new onset of symptoms: runny nose, nasal congestion, sore throat, cough, hoarse voice, shortness of breath / difficulty breathing

You may not qualify if…

• Unwilling to participate in 7-day follow-up or sign HIPAA waiver to obtain medical record if hospitalized
• Immunocompromised state or taking immunosuppressive or chemotherapeutic medications in the last 30 days (e.g. oral / inhaled steroids, Methotrexate, Cyclosporine, Chemotherapy, interferon therapy)
• Taking antibiotics or antiviral therapy in the last 14 days
• Received a live viral immunization in the last 14 days
• Clinical diagnosis of otitis media or recognizable viral syndrome (i.e., croup, varicella, stomatitis) at the time of enrollment
• Prior enrollment in the study

Where it is running

• PAS Research — Edinburg, Texas, United States (enrolling)
• PAS Research- Myrtle Avenue Pediatrics, Inc — Clearwater, Florida, United States (enrolling)
• PAS Research- Sandhill Pediatrics PA — Lutz, Florida, United States (enrolling)
• PAS Research — Tampa, Florida, United States (enrolling)
• Hometown Urgent Care — Huber Heights, Ohio, United States (enrolling)
• Hometown Urgent Care — Springfield, Ohio, United States (enrolling)
• PAS Research — Pittsburgh, Pennsylvania, United States (enrolling)
• Tribe — Charleston, South Carolina, United States (enrolling)
• Tribe- Parkside Pediatrics — Greenville, South Carolina, United States
• Avacare — Colton, California, United States

Full record on ClinicalTrials.gov

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