Validation of the FebriDx Test to Differentiate Bacterial and Non-Bacterial Infections in Children Ages 2 to 11 with Acute Respiratory Symptoms

What this Trial Is About

Researchers are evaluating the FebriDx test to determine how well it distinguishes between bacterial and non-bacterial causes in children aged 2 to 11 years who have a fever and suspected acute respiratory infection. This observational study involves febrile pediatric patients presenting to emergency departments, urgent care centers, or primary care offices. The goal is to assess the tests ability to detect a bacterial systemic immune response compared to expert clinical adjudication using a clinical reference algorithm including pathogen detection and immune response measures. The study involves using the FebriDx device, a rapid lateral flow immunoassay that detects elevated levels of host response proteins Myxovirus resistance protein A MxA and C-reactive protein CRP from a fingerstick blood sample. Children suspected of acute respiratory infection will undergo the FebriDx test during a single visit. The study is blinded and observational without experimental treatments or placebo groups. Participants will be assessed once at enrollment with the FebriDx test and clinical data collection. Researchers will review clinical signs, symptoms, and results from pathogen detection tests such as bacterial culture or multiplex PCR to adjudicate infection status. Follow-up includes a 7-day period to monitor outcomes. The main outcome measure is the performance of the FebriDx test in identifying bacterial infections on the day of testing.

FebriDx® Pediatric Validation Study