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
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
Inclusion Criteria3
- 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 Criteria6
- 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
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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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07211997