FebriDx testing to tell viral from bacterial infections in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multi-center, observational, blinded study enrolling febrile children aged 2–11 with suspected acute respiratory infections. Participants will receive a FebriDx point-of-care fingerstick test that detects MxA and CRP levels, and results will be compared to a clinical adjudication reference that includes pathogen detection (culture, PCR) and host-response measures. The primary outcome is whether a bacterial-associated systemic host immune response is present, as determined by the adjudication panel using a Clinical Reference Algorithm. Data will be collected at community EDs, urgent care centers, and primary care offices at multiple U.S. sites.

Why it matters

Who can join: the full rules

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

Where it's running

• PAS Research- Myrtle Avenue Pediatrics, Inc
  Clearwater, Florida, United States Recruiting
• PAS Research- Sandhill Pediatrics PA
  Lutz, Florida, United States Recruiting
• PAS Research
  Tampa, Florida, United States Recruiting
• Hometown Urgent Care
  Huber Heights, Ohio, United States Recruiting
• Hometown Urgent Care
  Springfield, Ohio, United States Recruiting
• PAS Research
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Catalina Suarez-Cuervo, MD
• Email: Clinicalstudies@lumosdiagnostics.com
• Phone: 7277765885

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.