MeMed BV® Test Evaluation in Adult Emergency Department Patients

NCT05706935 | Completed FDA Device

• 3 other identifiers: 2022-1612SMPH/EMERG MEDProtocol Version 1/13/2023
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Infection; Respiratory Infections in Old Age; Respiratory Infection Virus; Respiratory Infection Bacterial

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Biospecimen

Retention: NONE RETAINED

Saliva and mouth swabs, blood samples

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Michael Pulia, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 31, 2023
• Study Start: February 6, 2023
• Primary Completion: July 31, 2023
• Study Completion: January 31, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)