FebriDx® Pediatric Validation Study

NCT07211997 · tracked via the Priya Life Science USA tracker

Sponsor

Lumos Diagnostics

Phase

Observational

Started

2025-10-09

Last updated

2026-07-07

Condition(s) studied

Acute Respiratory Infections (ARIs)

Investigational drug(s) / intervention(s)

FebriDx

FebriDx: Bacterial/Non-Bacterial Point-of-Care Assay that detects the presence of MxA and CRP in fingerstick blood

Study 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.

Eligibility

Sex

ALL

Min age

2 Years

Max age

11 Years

Healthy volunteers

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

Primary outcome measure(s)

Performance of the FebriDx® test — Day 1
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.
FebriDx Performance — Single visit
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

Trial sites (10)

Facility	City	Region	Status
Avacare	Colton	California	Not Yet Recruiting
PAS Research- Myrtle Avenue Pediatrics, Inc	Clearwater	Florida	Recruiting
PAS Research- Sandhill Pediatrics PA	Lutz	Florida	Recruiting
PAS Research	Tampa	Florida	Recruiting
Hometown Urgent Care	Huber Heights	Ohio	Recruiting
Hometown Urgent Care	Springfield	Ohio	Recruiting
PAS Research	Pittsburgh	Pennsylvania	Recruiting
Tribe	Charleston	South Carolina	Recruiting
Tribe- Parkside Pediatrics	Greenville	South Carolina	Not Yet Recruiting
PAS Research	Edinburg	Texas	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07211997 on ClinicalTrials.gov ↗ ← All trials in the USA