MeMed BV® Test Evaluation in Adult Emergency Department Patients

Study Overview
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Brief Summary
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The goal of this observational study is to compare the results of a serum biomarker called the MeMed BV®, which is approved to help differentiate between bacterial and viral respiratory infections, to clinical diagnoses of adult emergency department patients presenting with recent fever and signs or symptoms of a respiratory infection. Active participation is completed during the emergency department visit and includes drawing blood, obtaining a sputum sample, and answering survey questions.

Detailed Description
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The MeMed BV® is a diagnostic test newly approved by the FDA to assess the likelihood of bacterial vs. viral respiratory infections based on protein biomarkers in blood. This study aims to identify the level of agreement between the results of the MeMed BV® (bacterial/viral) and the standard of care treatment received by the participant (e.g. antibiotics for patient diagnosed with bacterial pneumonia) in order to see if implementing the MeMed BV® into standard clinical care would potentially change diagnosis.

Official Title
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Evaluation of the MeMed BV® Test in Adult Emergency Department Patients With Fever and Acute Respiratory Symptoms

Conditions
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Respiratory Infection, Respiratory Infections in Old Age, Respiratory Infection Virus, Respiratory Infection Bacterial

Intervention / Treatment
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* Diagnostic Test: MeMed BV® test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults presenting to the emergency department Subjective or objective fever within the past 7 days Signs or symptoms of upper or lower respiratory tract infection within the past 7 days Exclusion Criteria: Prisoner Suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis Active inflammatory disease Congenital or acquired immune deficiency Chronic fungal or parasitic infection Infection with human immunodeficiency virus (HIV) Hepatitis B virus (HBV) Hepatitis C virus (HCV) Infection with active tuberculosis (TB) Significant trauma or burns in the last 7 days Patients that have undergone major surgery in the last 7 days Pregnancy Active malignancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: MeMed BV® test|The MeMed BV® test is an automated semiquantitative immunoassay that measures three nonmicrobial (host) proteins (TRAIL, IP-10, and CRP) in serum samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MeMed BV® test result and diagnostic concordance | Percent agreement between result of MeMed BV® test (bacterial or viral respiratory infection) and antibiotic prescribing by emergency medicine doctor (which implies suspected bacterial infection) | Emergency department 1 day visit |