FebriDx® Pediatric Validation Study

July 2, 2026 updated by: Lumos Diagnostics

FebriDx® Pediatric Validation Study Protocol

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multi-center, observational, blinded study where children with suspected acute respiratory infection will undergo FebriDx® testing.

The primary outcome is the presence of a bacterial associated systemic host immune response related to a febrile acute respiratory tract infection, as compared to the reference standard of clinical adjudication as determined by a panel of pediatric experts using the Clinical Reference Algorithm that includes pathogen detection testing (e.g., bacterial culture, multiplex PCR) as well as measures of host immune response.

FebriDx is a rapid lateral flow immunoassay for the visual, qualitative, in vitro detection of elevated levels of host response proteins, Myxovirus resistance protein A (MxA) and C-reactive protein (CRP), directly from fingerstick blood.

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Colton, California, United States, 92324
        • Not yet recruiting
        • Avacare
        • Principal Investigator:
          • Brian Bearie, MD
        • Contact:
    • Florida
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • PAS Research- Myrtle Avenue Pediatrics, Inc
        • Contact:
        • Principal Investigator:
          • Karen Kelly, MD
      • Lutz, Florida, United States, 33549
        • Recruiting
        • PAS Research- Sandhill Pediatrics PA
        • Contact:
        • Principal Investigator:
          • Wendy Masterman, MD
      • Tampa, Florida, United States, 33613
        • Recruiting
        • PAS Research
        • Contact:
        • Principal Investigator:
          • Teena Hughes, MD
    • Ohio
      • Huber Heights, Ohio, United States, 45424
        • Recruiting
        • Hometown Urgent Care
        • Principal Investigator:
          • Steve Choi, MD
        • Contact:
      • Springfield, Ohio, United States, 45504
        • Recruiting
        • Hometown Urgent Care
        • Principal Investigator:
          • Steve Choi, MD
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15227
        • Recruiting
        • PAS Research
        • Contact:
        • Principal Investigator:
          • Steven Twan, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Recruiting
        • Tribe
        • Contact:
        • Principal Investigator:
          • Philip McGaha, MD
      • Greenville, South Carolina, United States, 29607
        • Not yet recruiting
        • Tribe- Parkside Pediatrics
        • Principal Investigator:
          • Scott Dobson, MD
        • Contact:
    • Texas
      • Edinburg, Texas, United States, 78539
        • Recruiting
        • PAS Research
        • Contact:
        • Principal Investigator:
          • Allan Mercado, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients presenting to the emergency department, urgent care center or primary care office with a suspected acute respiratory tract infection

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: FebriDx
Bacterial/Non-Bacterial Point-of-Care Assay that detects the presence of MxA and CRP in fingerstick blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of the FebriDx® test
Time Frame: 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.
Day 1
FebriDx Performance
Time Frame: 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
Single visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lumos Diagnostics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

May 30, 2027

Study Registration Dates

First Submitted

October 1, 2025

First Submitted That Met QC Criteria

October 1, 2025

First Posted (Actual)

October 8, 2025

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CLP-0021
  • 75A50124C000051 (Other Grant/Funding Number: BARDA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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