FebriDx® Pediatric Validation Study
ConditionAcute Respiratory Infections (ARIs)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-11
SponsorLumos Diagnostics
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- FebriDx
Treatment groups
800 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov