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FebriDx® Pediatric Validation Study
RecruitingObservational study
FebriDx® Pediatric Validation Study Protocol
Who can join
Ages 2 to 11 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
About the study
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.
What is being tested
- FebriDx (device)
Sponsor: Lumos Diagnostics · Participants: 800 · Started: Oct 9, 2025
Contact the study team
- Catalina Suarez-Cuervo, MD · Phone: 7277765885
- Catherine Borgiasz, ACRP-CP · Phone: 941-779-3078
Official record on ClinicalTrials.gov — NCT07211997
Locations in the U.S.
| California | Avacare, Colton (Not yet recruiting) |
| Florida | PAS Research- Myrtle Avenue Pediatrics, Inc, Clearwater PAS Research- Sandhill Pediatrics PA, Lutz PAS Research, Tampa |
| Ohio | Hometown Urgent Care, Huber Heights Hometown Urgent Care, Springfield |
| Pennsylvania | PAS Research, Pittsburgh |
| South Carolina | Tribe, Charleston Tribe- Parkside Pediatrics, Greenville (Not yet recruiting) |
| Texas | PAS Research, Edinburg |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.