Evaluating the FebriDx test for respiratory infections
CLP-0019- FebriDx® Method Comparison Study Protocol
This study tests how well the FebriDx test can tell the difference between bacterial and non-bacterial respiratory infections when used by people without lab training.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 12 Years to 64 Years |
| Sex | All |
| Sponsor | Lumos Diagnostics Industry-sponsored |
| Drugs / interventions | chemotherapy, Methotrexate |
| Locations | 8 sites (Fullerton, California and 7 other locations) |
| Trial ID | NCT06746259 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the performance and usability of the FebriDx test when operated by individuals without laboratory training in patients exhibiting acute respiratory symptoms. The study will compare the accuracy of the FebriDx test in differentiating between bacterial and non-bacterial respiratory infections, focusing on its use by both trained and untrained operators. It will also gather data on the ease of use and subjective feedback from operators to ensure the test meets safety and performance standards for untrained environments.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 12 to 64 years presenting with acute respiratory symptoms and a fever within the last 72 hours.
Not a fit: Patients who are immunocompromised, receiving interferon therapy, or have symptoms lasting longer than 7 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing respiratory infections in non-laboratory settings, leading to better patient management.
How similar studies have performed: Previous studies have shown promise in point-of-care diagnostics for respiratory infections, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Fullerton, California and 7 other locations
- Ascada Health — Fullerton, California, United States (Recruiting)
- Exer Urgent Care — Pasadena, California, United States (Not_yet_recruiting)
- L&c — Miami, Florida, United States (Recruiting)
- Trujillo Medical Center — Miramar, Florida, United States (Recruiting)
- Hillcrest Medical Research, LLC — Orange City, Florida, United States (Recruiting)
- Hometown Urgent Care and Research — Beavercreek, Ohio, United States (Recruiting)
- HMG Clinical Research/Herrera Medical Group — Bedford, Texas, United States (Recruiting)
- Ascada Health — Katy, Texas, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Catalina Suarez-Cuervo, MD
- Email: Clinicalstudies@lumosdiagnostics.com
- Phone: 727-776-5880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.