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| ID | Type | Description | Link |
|---|---|---|---|
| SMPH/EMERG MED | Other Identifier | UW Madison | |
| Protocol Version 1/13/2023 | Other Identifier | UW Madison |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MeMed BV® test | Diagnostic 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adults presenting to the ED with history of recent fever and signs or symptoms of acute respiratory infection.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Pulia, MD, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 17, 2023 | Aug 29, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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Saliva and mouth swabs, blood samples