Respiratory Infection Clinical Trial
Official title:
Evaluation of the MeMed BV® Test in Adult Emergency Department Patients With Fever and Acute Respiratory Symptoms
Verified date | January 2024 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison |
United States,
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 |
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