Recruiting

FebriDx® Test

Sponsor:

Lumos Diagnostics

Code:

NCT07211997

Conditions

Acute Respiratory Infections (ARIs)

Eligibility Criteria

Sex: All

Age: 2 - 11

Healthy Volunteers: Not accepted

Interventions

FebriDx

Study Details

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.

Conditions

Acute Respiratory Infections (ARIs)

Study ID

NCT07211997

Start date

Oct 9, 2025

Status verified date

Jul, 2026

Completion date

May 30, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 11

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Arms

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

FebriDx

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

Primary outcome measure

  • Performance of the FebriDx® test [ Time Frame: Day 1 ]
  • FebriDx Performance [ Time Frame: Single visit ]

Central Contacts and Locations

Central contacts

Catalina Suarez-Cuervo, MD

7277765885Clinicalstudies@lumosdiagnostics.com

Catherine Borgiasz, ACRP-CP

941-779-3078Clinicalstudies@lumosdiagnostics.com

Locations

PAS Research- Myrtle Avenue Pediatrics, Inc

Recruiting

Clearwater, Florida, United States, 33756

Contacts

Brandi Baldwin

813-330-3199brandi8754@gmail.com

Principal Investigator:

Karen Kelly, MD

PAS Research- Sandhill Pediatrics PA

Recruiting

Lutz, Florida, United States, 33549

Contacts

Brandi Baldwin

813-330-3199brandi8754@gmail.com

Principal Investigator:

Wendy Masterman, MD

PAS Research

Recruiting

Tampa, Florida, United States, 33613

Contacts

Brandi Baldwin

813-330-3199brandi8754@gmail.com

Principal Investigator:

Teena Hughes, MD

Hometown Urgent Care

Recruiting

Huber Heights, Ohio, United States, 45424

Contacts

Sherri Price

937-236-8630sprice@myhometownuc.com

Principal Investigator:

Steve Choi, MD

Hometown Urgent Care

Recruiting

Springfield, Ohio, United States, 45504

Contacts

Sankeerth Motupalli

937-322-6222smotupalli@myhometownuc.com

Principal Investigator:

Steve Choi, MD

PAS Research

Recruiting

Pittsburgh, Pennsylvania, United States, 15227

Contacts

Kristy Cramer

813-330-3199kristy@pas-research.com

Principal Investigator:

Steven Twan, MD

Tribe

Recruiting

Charleston, South Carolina, United States, 29407

Contacts

Christine Butler

843-766-6093cbutler@tribecr.com

Principal Investigator:

Philip McGaha, MD

PAS Research

Recruiting

Edinburg, Texas, United States, 78539

Contacts

Zulma Pacheco

813-330-3199zulma@pas-research.com

Principal Investigator:

Allan Mercado, MD

More Information

Sponsor

Lumos Diagnostics

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • Pediatric
  • Host immune response
  • Biomarkers
  • Point-of-Care
  • Myxovirus resistance protein A (MxA)
  • C-reactive protein (CRP)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Lumos Diagnostics on 2026-07-07.