Actively Recruiting
FebriDx® Pediatric Validation Study
Led by Lumos Diagnostics · Updated on 2025-10-31
800
Participants Needed
10
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FebriDx® Pediatric Validation Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent by parent or guardian and assent for children aged 7 to 11 years
- New measured temperature of at least 100.4 F (38 0C) within 3 days (72 hours) before enrollment
- Clinical suspicion of acute respiratory infection starting within 7 days before enrollment
- Presence of at least one new symptom: runny nose, nasal congestion, sore throat, cough, hoarse voice, or shortness of breath/difficulty breathing
You will not qualify if you...
- Unwillingness to participate in 7-day follow-up or sign HIPAA waiver if hospitalized
- Immunocompromised condition or use of immunosuppressive or chemotherapy medications in the past 30 days
- Use of antibiotics or antiviral therapy within 14 days prior to enrollment
- Receipt of live viral vaccine within 14 days before enrollment
- Clinical diagnosis of otitis media or recognizable viral syndrome (e.g., croup, varicella, stomatitis) at enrollment
- Prior enrollment in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Avacare
Colton, California, United States, 92324
Not Yet Recruiting
2
PAS Research- Myrtle Avenue Pediatrics, Inc
Clearwater, Florida, United States, 33756
Actively Recruiting
3
PAS Research- Sandhill Pediatrics PA
Lutz, Florida, United States, 33549
Actively Recruiting
4
PAS Research
Tampa, Florida, United States, 33613
Actively Recruiting
5
Hometown Urgent Care
Huber Heights, Ohio, United States, 45424
Actively Recruiting
6
Hometown Urgent Care
Springfield, Ohio, United States, 45504
Actively Recruiting
7
PAS Research
Pittsburgh, Pennsylvania, United States, 15227
Actively Recruiting
8
Tribe
Charleston, South Carolina, United States, 29407
Actively Recruiting
9
Tribe- Parkside Pediatrics
Greenville, South Carolina, United States, 29607
Not Yet Recruiting
10
PAS Research
Edinburg, Texas, United States, 78539
Actively Recruiting
Research Team
C
Catalina Suarez-Cuervo, MD
CONTACT
C
Catherine Borgiasz, ACRP-CP
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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