FebriDx® Pediatric Validation 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
| Condition(s) | Acute Respiratory Infections (ARIs) |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 | 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, Methotrexat |
| Ages | 2 Years to 11 Years |
| Sex | All |
| Lead sponsor | Lumos Diagnostics |
| Locations | Colton, California, United States; Clearwater, Florida, United States; Lutz, Florida, United States; Tampa, Florida, United States; Huber Heights, Ohio, United States; Springfield, Ohio, United States (+4 more sites) |
| Start date | 2025-10-09 |
| NCT ID | NCT07211997 |
| Official listing | https://clinicaltrials.gov/study/NCT07211997 |