MeMed BV® Test Evaluation in Adult Emergency Department Patients

Respiratory Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05706935
• Other study ID #: 2022-1612
• Secondary ID: SMPH/EMERG MEDPr
• Status: Completed
• Start date: February 6, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: January 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: January 31, 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Emergencies
• Infections
• Respiratory Infection
• Respiratory Infections in Old Age
• Respiratory Tract Infections

Intervention

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.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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