FebriDx® Method Comparison Study Protocol

Description

The goal of this observational study is to learn about the performance and ease of use of FebriDx when operated by persons without laboratory experience or training in patients with acute respiratory symptoms. The main question it aims to answer is: • Is FebriDx accurate at differentiating bacterial from non-bacterial respiratory infections when used by untrained operators? Trained and untrained participants will run the FebriDx test on patients with respiratory symptoms to evaluate comparability.

Conditions

Acute Respiratory Infections (ARIs)

Talk to us

Study Overview

On this page

Study Details

Study overview

The goal of this observational study is to learn about the performance and ease of use of FebriDx when operated by persons without laboratory experience or training in patients with acute respiratory symptoms. The main question it aims to answer is: • Is FebriDx accurate at differentiating bacterial from non-bacterial respiratory infections when used by untrained operators? Trained and untrained participants will run the FebriDx test on patients with respiratory symptoms to evaluate comparability.

CLP-0019- FebriDx® Method Comparison Study Protocol

FebriDx® Method Comparison Study Protocol

Condition
Acute Respiratory Infections (ARIs)
Intervention / Treatment

-

Contacts and Locations

Fullerton

Ascada Health, Fullerton, California, United States, 92835

Pasadena

Exer Urgent Care, Pasadena, California, United States, 91105

Miami

L&C, Miami, Florida, United States, 33144

Miramar

Trujillo Medical Center, Miramar, Florida, United States, 33027

Orange City

Hillcrest Medical Research, LLC, Orange City, Florida, United States, 32763

Beavercreek

Hometown Urgent Care and Research, Beavercreek, Ohio, United States, 45430

Bedford

HMG Clinical Research/Herrera Medical Group, Bedford, Texas, United States, 76021

Katy

Ascada Health, Katy, Texas, United States, 77494

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Subject exhibits or reports a new onset measured temperature (oral or tympanic) of greater than or equal to 100.5°F/38°C within 3 days (72 hours) of enrollment or at the visit
  • * Subject has clinical suspicion for Acute Respiratory Infection and presents with at least one (1) of the following new onset symptoms beginning ≤ 7 days of enrollment: runny nose, nasal congestion, sore throat, cough, hoarse voice or shortness of breath
  • * Subject is unable or unwilling to provide signed, Informed Consent
  • * Subject is less than 12 years old or over 64 years old
  • * Subject has a fever that started more than 3 days (\> 72 hours) prior to enrollment
  • * Subject has symptoms of Acute Respiratory Infection that started \> 7 days of enrollment
  • * Subject is receiving interferon therapy (e.g. MS, HIV, HBV, HCV) in the last 30 days
  • * Subject is in an immunocompromised state (e.g. HIV) or taking immunosuppressive or chemotherapeutic medications in the last 30 days (e.g. oral steroids, Methotrexate, Cyclosporine, Antimetabolite chemotherapy, interferon therapy)
  • * Subject has taken antibiotics or antiviral therapy in the last 14 days
  • * Subject received a live viral immunization in the last 14 days
  • * Subject has significant trauma or burns (\> 5% total body surface area or full thickness (3rd°)) in the last 30 days
  • * Subject has had major surgery (requiring intravenous anesthesia and/or respiratory assistance) in the last 30 days
  • * Subject has a history of a myocardial infarction or stroke in the last 30 days

Ages Eligible for Study

12 Years to 64 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Lumos Diagnostics,

Study Record Dates

2025-06-15