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FebriDx® Pediatric Validation Study

Recruitingn/aAges 2 Years - 11 YearsAllLumos Diagnostics
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • FebriDx
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Where

10 sites
Avacare
Colton, United States
PAS Research- Myrtle Avenue Pediatrics, Inc
Clearwater, United States
PAS Research- Sandhill Pediatrics PA
Lutz, United States
PAS Research
Tampa, United States
Hometown Urgent Care
Huber Heights, United States
Hometown Urgent Care
Springfield, United States
PAS Research
Pittsburgh, United States
Tribe
Charleston, United States

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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