FebriDx® Pediatric Validation Study (NCT07211997) | Clinical Trial Compass
RecruitingNot Applicable
FebriDx® Pediatric Validation Study
United States800 participantsStarted 2025-10-09
Plain-language 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.
Who can participate
Age range2 Years – 11 Years
SexALL
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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