MeMed BV® Test for Infections
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new tool, the MeMed BV® biomarker test, to determine if it helps doctors better manage respiratory infections. Researchers aim to find out if this test can improve care and reduce hospital stays compared to usual practices. Individuals with symptoms of a respiratory infection, such as a fever for seven days or less, might be suitable for this study. As an unphased trial, participants can contribute to innovative research that may enhance future healthcare practices.
Will I have to stop taking my current medications?
The trial requires that you have not taken systemic antibiotics or outpatient steroids within 48 hours before joining. If you are on immune-suppressive or immune-modulating therapies, you should not have taken them in the past 10 days.
What prior data suggests that the MeMed BV® biomarker test is safe for use in patient management?
Research has shown that the MeMed BV® test, approved by the FDA, helps doctors determine if an infection is bacterial or viral by checking protein levels in the blood. Studies have found the test to be highly accurate, with over 98% certainty in ruling out bacterial infections when the result is negative.
This indicates that the test is generally safe to use. As a diagnostic tool rather than a medication, it doesn't carry the same risk of side effects that drugs might have. No reports of negative effects from the test itself exist. Therefore, it is well-tolerated and should not pose safety concerns for those considering participation in a trial using this test.12345Why are researchers excited about this trial?
The MeMed BV® biomarker test is unique because it offers a new way to assess acute respiratory infections by providing a clinical score from 1 to 100. Unlike standard treatments that rely on clinical judgment and existing protocols, this test gives doctors an additional tool to better allocate resources and make more informed decisions. Researchers are excited because this could lead to more precise and timely treatments, potentially improving patient outcomes significantly.
What evidence suggests that the MeMed BV® biomarker test is effective for managing infections?
Research has shown that the MeMed BV® test distinguishes between bacterial and viral infections by analyzing the immune system's response. In just 15 minutes, it provides a score that aids doctors in selecting the appropriate treatment. In this trial, one group of participants will receive the standard care for acute respiratory infections, while another group will receive the MeMed BV® test in addition to the standard care. Studies have found that using this test in emergency rooms can quickly rule out bacterial infections, potentially reducing unnecessary antibiotic use. In children, those with higher scores for bacterial infections on the test were more likely to have pneumonia confirmed by an X-ray. Overall, the MeMed BV® test enables doctors to make faster and more accurate treatment decisions for respiratory infections.12678
Who Is on the Research Team?
David Robinson, MD,MS,MMM
Principal Investigator
The University of Texas Health Science Center, Houston
Are You a Good Fit for This Trial?
This trial is for individuals with suspected bacterial or viral respiratory infections, who have had a fever recently and are within the first week of their illness. They must not have taken antibiotics in the last 48 hours or immune therapies in the past 10 days. Excluded are pregnant women, cancer patients, those with certain immune deficiencies or infections like HIV/HBV/HCV, recent major trauma/surgery patients, and anyone deemed unsuitable by the study team.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Emergency Department Evaluation
Participants are evaluated in the ED for acute respiratory infections and undergo standard care or additional diagnostic testing
Hospital Stay
Participants may be admitted to the hospital for further management based on the diagnostic test results and clinical judgment
Follow-up
Participants are monitored for bounce backs and resource utilization after discharge
What Are the Treatments Tested in This Trial?
Interventions
- MeMed BV® biomarker test
- Usual care
Trial Overview
The study is testing whether adding MeMed BV® biomarker test to usual care can improve decision-making in emergency departments for people with respiratory infections. It looks at how this affects patient management such as additional tests, treatments given, hospital stay duration and overall resource use.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
In addition to the standard of care for acute respiratory infections, the experimental arm shall reveal the results of the 'BV' test to the clinician co-investigators. The BV test reports a clinical score from 1-100 that as an adjunct to usual care, may help the clinician better direct appropriate resources towards the patient.
The co-investigators shall evaluate, diagnose and manage the acute respiratory infection presenting to the ED using the standard practice known in the community. This may include hospital sepsis practice protocols, clinical judgement, and national or local practice standards.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor
MeMed Diagnostics Ltd.
Industry Sponsor
Citations
Real-World Utility of the Host-Response MeMed BV Test in a ...
In this study, we evaluated the clinical utility of MMBV in a Greek pediatric population with acute infections at the time of clinical ...
MeMed BV® | Distinguishing Bacterial from Viral Infections
MeMed BV® analyzes host immune response to distinguish between bacterial and viral infections in 15 minutes—helping clinicians make fast, ...
MeMed BV® Test Evaluation in Adult Emergency ...
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 ...
Evaluation of a novel host protein-based assay for ruling ...
MeMed BV test is effective for rapidly ruling out bacterial infection in the ED. •. Using MeMed BV may help reduce unnecessary antibiotic use in the ED.
5.
publications.aap.org
publications.aap.org/hospitalpediatrics/article/14/11/881/199625/The-Association-of-the-MeMed-BV-Test-WithThe Association of the MeMed BV Test With Radiographic ...
Children with moderate to high likelihoods of bacterial infection on the BV test had higher odds of radiographic pneumonia.
Real-World Study Assessing Sensitivity and Clinical Utility ...
MeMed BV (MMBV) is a Food and Drug Administration-cleared host-protein test with >98% negative predictive value (NPV) for distinguishing bacterial (including ...
MeMed BV Bacterial Viral Immunoassay Test
MeMed BV is a regulatory-cleared host-immune response assay for accurately distinguishing between bacterial and viral infections within the ED workflow in just ...
8.
contagionlive.com
contagionlive.com/view/from-pathogen-to-infectious-disease-diagnosis-test-determines-between-bacterial-and-viral-infections-in-15-minutesTest Determines Between Bacterial and Viral Infections ...
Eden's company developed a novel assay, the MeMed BV test, that can distinguish between bacterial and viral infections in 15 minutes.
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