FebriDx® Pediatric Validation Study

Recruiting Observational Study
Acute Respiratory Infections (ARIs)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
2 – 11
Sex
Any
Study type
Observational
Participants needed
800 (estimated)
Sponsor
Lumos Diagnostics · Industry
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About This Trial

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 Locations
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Eligibility 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 Infec…
Contacts

Catalina Suarez-Cuervo, MD

7277765885

Clinicalstudies@lumosdiagnostics.com

CONTACT

Catherine Borgiasz, ACRP-CP

941-779-3078

Clinicalstudies@lumosdiagnostics.com

CONTACT