FebriDx® Method Comparison Study Protocol
Completed
Conditions studied: Acute Respiratory Infections (ARIs)
In brief
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.
Key facts
- Study ID
- NCT06746259
- Run by
- Lumos Diagnostics
- People needed
- 800
- Starts
- 2024-12-20
- Expected to finish
- 2025-08-31
- Last updated by the study team
- 2025-09-09
Who can join
Age: 12 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Ascada Health — Fullerton, California, United States
- Exer Urgent Care — Pasadena, California, United States
- L&C — Miami, Florida, United States
- Trujillo Medical Center — Miramar, Florida, United States
- Hillcrest Medical Research, LLC — Orange City, Florida, United States
- Hometown Urgent Care and Research — Beavercreek, Ohio, United States
- HMG Clinical Research/Herrera Medical Group — Bedford, Texas, United States
- Ascada Health — Katy, Texas, United States
Full record on ClinicalTrials.gov
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