COMPLETED

FebriDx® Method Comparison Study Protocol

Conditions

Acute Respiratory Infections (ARIs)Point of care diagnostics CRP (C- Reactive Protein)MxA (Myxovirus resistance protein A)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

CLP-0019- FebriDx® Method Comparison Study Protocol

Quick Facts

Study Start:2024-12-20

Study Completion:2025-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06746259

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.

Ages Eligible for Study:12 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Locations (Sites)

Ascada Health

Fullerton, California, 92835

United States

Exer Urgent Care

Pasadena, California, 91105

United States

L&C

Miami, Florida, 33144

United States

Trujillo Medical Center

Miramar, Florida, 33027

United States

Hillcrest Medical Research, LLC

Orange City, Florida, 32763

United States

Hometown Urgent Care and Research

Beavercreek, Ohio, 45430

United States

HMG Clinical Research/Herrera Medical Group

Bedford, Texas, 76021

United States

Ascada Health

Katy, Texas, 77494

United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2024-12-20

Study Completion Date2025-08-31

Study Record Updates

Study Start Date2024-12-20

Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

Point of care diagnostics
CRP (C- Reactive Protein)
MxA (Myxovirus resistance protein A)

Additional Relevant MeSH Terms

Acute Respiratory Infections (ARIs)