Trials / Completed
CompletedNCT05706935
MeMed BV® Test Evaluation in Adult Emergency Department Patients
Evaluation of the MeMed BV® Test in Adult Emergency Department Patients With Fever and Acute Respiratory Symptoms
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 111 (actual)
- Sponsor
- University of Wisconsin, Madison · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
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.
Conditions
- Respiratory Infection
- Respiratory Infections in Old Age
- Respiratory Infection Virus
- Respiratory Infection Bacterial
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-02-06
- Primary completion
- 2023-07-31
- Completion
- 2024-01-31
- First posted
- 2023-01-31
- Last updated
- 2024-02-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05706935. Inclusion in this directory is not an endorsement.