FebriDx® Pediatric Validation Study
2 other identifiers
observational
800
1 country
10
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 years) presenting to the emergency department, urgent care center or primary care office with a suspected acute respiratory tract infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2025
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2025
CompletedFirst Posted
Study publicly available on registry
October 8, 2025
CompletedStudy Start
First participant enrolled
October 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2026
October 31, 2025
October 1, 2025
1.1 years
October 1, 2025
October 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Performance of the FebriDx® test
Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) of the FebriDx results in determining the presence of a bacterial associated systemic host immune response compared to the reference standard of clinical adjudication as determined by a panel of pediatric experts using the Clinical Reference Algorithm.
Day 1
FebriDx Performance
Positive and negative percent agreement Presence of a bacterial associated systemic host immune response related to a febrile acute respiratory tract infection, as compared to the reference standard
Single visit
Study Arms (1)
Acute Respiratory Infection
Febrile pediatric patients (2-11 years) presenting to the emergency department, urgent care centers or primary care offices with suspected acute respiratory tract infection.
Interventions
Bacterial/Non-Bacterial Point-of-Care Assay that detects the presence of MxA and CRP in fingerstick blood
Eligibility Criteria
Pediatric patients presenting to the emergency department, urgent care center or primary care office with a suspected acute respiratory tract infection
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Avacare
Colton, California, 92324, United States
PAS Research- Myrtle Avenue Pediatrics, Inc
Clearwater, Florida, 33756, United States
PAS Research- Sandhill Pediatrics PA
Lutz, Florida, 33549, United States
PAS Research
Tampa, Florida, 33613, United States
Hometown Urgent Care
Huber Heights, Ohio, 45424, United States
Hometown Urgent Care
Springfield, Ohio, 45504, United States
PAS Research
Pittsburgh, Pennsylvania, 15227, United States
Tribe
Charleston, South Carolina, 29407, United States
Tribe- Parkside Pediatrics
Greenville, South Carolina, 29607, United States
PAS Research
Edinburg, Texas, 78539, United States
Biospecimen
Respiratory and blood specimens will be retained for future testing.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2025
First Posted
October 8, 2025
Study Start
October 9, 2025
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
November 30, 2026
Last Updated
October 31, 2025
Record last verified: 2025-10