MeMed BV® Test Evaluation in Adult Emergency Department Patients

January 31, 2024 updated by: University of Wisconsin, Madison

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults presenting to the ED with history of recent fever and signs or symptoms of acute respiratory infection.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Emergency department 1 day visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Michael Pulia, MD, PhD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2023

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

January 20, 2023

First Submitted That Met QC Criteria

January 30, 2023

First Posted (Actual)

January 31, 2023

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-1612
  • SMPH/EMERG MED (Other Identifier: UW Madison)
  • Protocol Version 1/13/2023 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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