Clinical trial NCT06746259: FebriDx® Method Comparison Study Protocol
Official title: CLP-0019- FebriDx® Method Comparison Study Protocol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Infections (ARIs)
Keywords: Point of care diagnostics
CRP (C- Reactive Protein)
MxA (Myxovirus resistance protein A)
Lead sponsor: Lumos Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
First posted: 2024-12-24
Enrollment: 800
Sex: ALL
Minimum age (years): 12
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Symptomatic patients presenting to outpatient settings (e.g., physician offices, clinics, urgent care centers) with recent fever (reported within the last 72h) and recent symptoms of acute respiratory infection (symptoms reported to have started ≤ 7 days prior to study visit).

Brief summary: 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.

Detailed description: A prospective, multi-center, blinded observational study to demonstrate that the FebriDx test meets the CLIA statutory criteria for waiver by providing sufficient assurance that the addition of a new operator population (untrained) and environment of use (waived) will not adversely impact the performance or safety of the test.

The study aims to:

* Demonstrate that FebriDx® Test is accurate and the operator can perform the test with a negligible risk of erroneous result.
* As a secondary objective, ease-of-use objective data and subjective feedback relating to the device and its operator interface will be collected at the end of the study and assessed for comparability.

Eligibility criteria: Inclusion 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Performance
timeFrame: Day 1
Secondary outcomes:
measure: Usability
timeFrame: Day 1
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Ascada Health
state: California
city: Pasadena
country: United States
facility: Exer Urgent Care
state: California
city: Miami
country: United States
facility: L&C
state: Florida
city: Miramar
country: United States
facility: Trujillo Medical Center
state: Florida
city: Orange City
country: United States
facility: Hillcrest Medical Research, LLC
state: Florida
city: Beavercreek
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Bedford
country: United States
facility: HMG Clinical Research/Herrera Medical Group
state: Texas
city: Katy
country: United States
facility: Ascada Health
state: Texas
Study officials:
References: