FebriDx testing to tell viral from bacterial infections in children
FebriDx® Pediatric Validation Study Protocol
This study will test whether the FebriDx fingerstick test can tell bacterial from non-bacterial causes of fever in children ages 2–11 who come to emergency, urgent care, or primary care with respiratory symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 2 Years to 11 Years |
| Sex | All |
| Sponsor | Lumos Diagnostics Industry-sponsored |
| Drugs / interventions | Chemotherapy, Methotrexate |
| Locations | 10 sites (Colton, California and 9 other locations) |
| Trial ID | NCT07211997 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children aged 2–11 with a measured or reported fever ≥100.4°F (≥38°C) within 72 hours and new onset respiratory symptoms who present to a participating ED, urgent care, or primary care clinic and whose parent/guardian can provide consent (and assent when appropriate).
Not a fit: Children who are immunocompromised, have taken antibiotics or antivirals in the prior 14 days, received a live vaccine in the prior 14 days, are outside the 2–11 age range, or cannot complete follow-up are unlikely to benefit from this validation effort.
Why it matters
Potential benefit: If successful, this test could help clinicians quickly identify likely bacterial infections in children, reducing unnecessary antibiotics and enabling faster appropriate care.
How similar studies have performed: Similar FebriDx and MxA/CRP point-of-care approaches have shown promising accuracy in adults and small pediatric cohorts, but comprehensive pediatric validation is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Colton, California and 9 other locations
- Avacare — Colton, California, United States (Not_yet_recruiting)
- 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)
- Tribe — Charleston, South Carolina, United States (Recruiting)
- Tribe- Parkside Pediatrics — Greenville, South Carolina, United States (Not_yet_recruiting)
- PAS Research — Edinburg, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Catalina Suarez-Cuervo, MD
- Email: Clinicalstudies@lumosdiagnostics.com
- Phone: 7277765885
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.