Status:
RECRUITING
FebriDx® Pediatric Validation Study
Lead Sponsor:
Lumos Diagnostics
Conditions:
Acute Respiratory Infections (ARIs)
Eligibility:
All Genders
2-11 years
Brief 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 yea...
Detailed Description
This is a prospective, multi-center, observational, blinded study where children with suspected acute respiratory infection will undergo FebriDx® testing. The primary outcome is the presence of a bac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 9 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT07211997
Start Date
October 9 2025
End Date
November 30 2026
Last Update
October 31 2025
Active Locations (10)
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1
Avacare
Colton, California, United States, 92324
2
PAS Research- Myrtle Avenue Pediatrics, Inc
Clearwater, Florida, United States, 33756
3
PAS Research- Sandhill Pediatrics PA
Lutz, Florida, United States, 33549
4
PAS Research
Tampa, Florida, United States, 33613