RNA Biosignatures: A Paradigm Change for the Management of Young Febrile Infants

Every year ~500,000 infants present to EDs in the U.S. with fever as their presenting complaint. Six to 10% of these febrile infants will have invasive bacterial infections. Because there is no single reliable clinical or laboratory predictor of bacterial infections, clinicians depend of varying combinations of blood, urine, and cerebrospinal fluid (CSF) testing. These tests are invasive, often times inaccurate, and do not provide results quickly enough for ED disposition decisions.

The ultimate goal of this study protocol is to develop new, precise diagnostic tools that allow for less invasive, more accurate, and more timely evaluation and diagnosis of young febrile infants in the ED. This will be done by examining the patient’s immune response to bacterial and viral organisms, using RNA microarrays, and identify biosignatures that correctly classify the infants into bacterial, viral, co-infection, or uninfected groups. This study will prospectively gather clinical and RNA data on febrile infants <= 60 days of age who are being evaluated for bacterial infections in all PECARN EDs. Enrollment began in June 2016.