MeMed BV® Test Evaluation in Adult Emergency Department Patients

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.

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Key information

Conditions

Respiratory Infection Infections Respiratory Infection Bacterial Respiratory Infection Virus Respiratory Infections in Old Age Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

MeMed BV® test result and diagnostic concordance

Time frame: Emergency department 1 day visit

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)

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2024
First posted: Jan 31, 2023
Registry last updated: Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed