One of the ongoing challenges for clinicians is determining if infections are either bacterial or viral. Their presentation can be similar, and testing to determine if infections are the former or the latter can be time consuming. Clinicians want to make sure their patients are getting some type of intervention, so broad-spectrum antibiotics can often be prescribed in these cases.
A novel assay, the MeMed BV test, can distinguish between bacterial and viral infections in 15 minutes. The test received a FDA 510(k) clearance last year and also has the European CE Mark.1
A new study, the JUNO trial, was conducted by the manufacturer and demonstrated a 62% relative reduction in unnecessary antibiotic prescription rates—33% in the control group versus 13% in the MeMed BV (MMBV) group (p=0.003). Importantly, follow-up data indicated no significant increase in the rate of return emergency departments (EDs) and urgent care centers (UCCs) visits within 7 days, with 4.7% in the control group compared to 3.8% in the MeMed BV group. The data was presented at the ongoing ACEP24 Scientific Assembly by Adam Singer, MD, vice chairman for Research and Professor, Department of Emergency Medicine, Renaissance School of Medicine, Stony Brook University, New York.1
The JUNO trial is a randomized controlled trial conducted across 11 EDs and UCCs in the US and Israel. It enrolled 260 adult patients with clinical suspicion of lower respiratory tract infection (LRTI). The first small-scale analysis of data from the trial, which focused on a subgroup of 160 patients.1
“These preliminary results underscore the potential of MeMed BV to significantly influence antibiotic stewardship, reducing unwarranted antibiotic prescriptions while enhancing patient outcomes. We are now recruiting for a larger randomized controlled trial, which will further solidify the clinical value of the test," Singer said in a statement.1
What You Need to Know
The MeMed BV test, which distinguishes between bacterial and viral infections in just 15 minutes, demonstrated a 62% reduction in unnecessary antibiotic prescriptions in the JUNO trial, highlighting its potential to improve antibiotic stewardship and reduce overuse.
In the JUNO trial, patients in the MeMed BV group had lower rates of return to emergency departments and urgent care centers within 7 days, showcasing that reduced antibiotic use did not compromise patient outcomes.
IDSA updated guidelines to manage antimicrobial-resistant infections.
Combating Gram-Negative Infections
These infections are particularly challenging for clinicians especially as antimicrobial resistance continues to be an ongoing issue. Patients in some treatment environments, such as long-term care settings, may be delayed in getting diagnosed, and often patients can be given broad-spectrum antibiotics that may be limited in efficacy and leads to switching antibiotics and more exposure to these therapies and the possibility of antimicrobial resistance (AMR). One of the more important, emerging concepts is the Time-to-Treat paradigm, which is essential to getting patients antimicrobials with susceptibility to infections in an efficient time span.
Addressing gram-negative antimicrobial resistant infections has been a significant issue, and the Infectious Diseases Society of America (IDSA) decided to update treatment guidance this year. Back in August, the organization released updated guidance for managing antimicrobial resistant infections, including those caused by extended-spectrum β-lactamase-producing Enterobacterales (ESBL-E), AmpC β-lactamase-producing Enterobacterales (AmpC-E), carbapenem-resistant Enterobacterales (CRE), difficult-to-treat Pseudomonas aeruginosa (DTR P. aeruginosa), carbapenem-resistant Acinetobacter baumannii (CRAB), and Stenotrophomonas maltophilia.2
The MeMed BV test's manufacturer, Haifa Israel-based, MeMed, is planning to continue with studies. "The results of this trial build on a decade-long series of studies involving thousands of patients, demonstrating the high performance of the MeMed BV technology,” MeMed's co-founder and CEO Dr. Eran Eden, said in a statement. “This trial marks a significant step forward by generating interventional data and showcasing the test's actual impact on patients. We are committed to further expanding on these findings, with several additional utility and real-world studies underway. We are deeply grateful to Diasorin and BARDA for supporting this trial and for advancing the host-response field."1
References
2. Infectious Diseases Society of America. IDSA 2024 Guidance on the Treatment of Antimicrobial Resistant Gram-Negative Infections. Published Clinical Infectious Diseases July 12, 2024. Accessed August 7, 2024. https://www.idsociety.org/practice-guideline/amr-guidance/
