MeMed BV Test for Respiratory Infection
Recruiting in Palo Alto (17 mi)
+11 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: MeMed Diagnostics Ltd.
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
This is a Prospective, multi-center study enrolling adults subjects presented to the ED/Urgent care, with symptoms consistent with lower respiratory infection (LRTI). The reason of this study is to demonstrate the MeMed BV can help clinicians make decisions about using antibiotics in patients with lower respiratory track infections and see how it would impact clinical outcomes, antibiotics use, hospitalizations, ED clinicians find ways to improve health and medical care.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications. However, you cannot have taken systemic antibiotics within 72 hours before joining, and you cannot be on active treatment with certain immune-suppressive or immune-modulating therapies.
What data supports the idea that MeMed BV Test for Respiratory Infection is an effective treatment?
The available research shows that the MeMed BV Test is effective in distinguishing between bacterial and viral infections, which is crucial for appropriate treatment. This test helps reduce the over-prescription of antibiotics by accurately identifying the type of infection, as seen in studies involving patients with community-acquired pneumonia. By using this test, doctors can make better decisions about whether antibiotics are needed, leading to better patient outcomes and cost savings in emergency departments.12345
What safety data exists for the MeMed BV Test for Respiratory Infection?
The provided research does not contain specific safety data for the MeMed BV Test for Respiratory Infection. The articles focus on vaccine safety monitoring systems and adverse event reporting for vaccines like COVID-19, HPV, and varicella, but do not mention the MeMed BV Test or its safety data.678910
Research Team
Eligibility Criteria
Adults over 18 with symptoms of lower respiratory tract infections (LRTI) such as cough or chest discomfort, who haven't taken antibiotics in the last 72 hours. Participants must have a fever and be suspected to need antibiotics. Excluded are those with recent major trauma, active cancer, certain immune conditions, recent surgery, or known HIV/HBV/HCV.Inclusion Criteria
I have symptoms like coughing or difficulty breathing, suggesting a lung infection.
My doctor is considering prescribing me antibiotics.
My illness has been present for 7 days or less.
See 3 more
Exclusion Criteria
I have not taken antibiotics in the 3 days before my emergency or urgent care visit.
You were born with a weakened immune system.
I am suspected of or have been diagnosed with an infectious stomach/intestinal infection.
See 9 more
Treatment Details
Interventions
- MeMed BV test (Diagnostic Test)
Trial OverviewThe trial is testing the MeMed BV test's effectiveness in guiding antibiotic use for patients with LRTI in emergency and urgent care settings. It aims to see if this can improve patient outcomes and reduce unnecessary antibiotic prescriptions.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Adults with suspected Lower Respiratory Track Infection (LRTI)- The MeMed BV armExperimental Treatment1 Intervention
ED and urgent care center patients over the age of 18 years , with clinical suspicion of Lower Respiratory Track Infection. clinician will receive the BV result, this will include a recommendation regarding antibiotic treatment. A telephone FU call will be done at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness
Group II: Adults with suspected Lower Respiratory Track Infection (LRTI)- The control armActive Control1 Intervention
ED and urgent care center patients over the age of 18 years , with clinical suspicion of Lower Respiratory Track Infection. clinician will not receive the BV result, and will treat according to standard of care. A telephone FU call will be done at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Philadelphia Thomas Jefferson Urgent CarePhiladelphia, PA
UT Southwestern Medical CenterDallas, TX
University of Florida-JacksonvilleJacksonville, FL
Maimonides Medical CenterBrooklyn, NY
More Trial Locations
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Who Is Running the Clinical Trial?
MeMed Diagnostics Ltd.
Lead Sponsor
Trials
17
Patients Recruited
14,700+
Findings from Research
The MeMed-BV test demonstrated high diagnostic sensitivity (94%) and specificity (88%) for distinguishing between bacterial infections and viral infections in a study of 60 pediatric patients, indicating its efficacy in clinical settings.
This immunoassay showed excellent agreement with manufacturer data and outperformed traditional infection-related biomarkers, suggesting it could improve diagnosis and treatment timelines for pediatric patients with acute febrile illness.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Validation of a multi-analyte immunoassay for distinguishing bacterial vs. viral infections in a pediatric cohort.Chokkalla, AK., Tam, E., Liang, R., et al.[2023]
The LIAISON® MeMed BV® (LMMBV) test can effectively differentiate between bacterial and viral infections in patients with community-acquired pneumonia, leading to a significant reduction in unnecessary antibiotic prescriptions and treatment duration.
Implementing LMMBV in emergency departments could save up to EUR 364 per patient for hospitals in Italy and Germany, and EUR 165 in Spain, highlighting its potential for both clinical and economic benefits in healthcare systems.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Cost-Impact Analysis of a Novel Diagnostic Test to Assess Community-Acquired Pneumonia Etiology in the Emergency Department Setting: A Multi-Country European Study.Houshmand, H., Porta, C., Pradelli, L., et al.[2023]
The MeMed BV® platform, which measures three host proteins (TRAIL, IP-10, and CRP), effectively differentiates between bacterial and viral infections, providing a score that helps clinicians make informed decisions.
In a reproducibility study involving multiple sites and analyzers, the platform demonstrated reliable performance with low variability in protein measurements, supporting its potential as a rapid diagnostic tool for acute infections.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A point-of-need platform for rapid measurement of a host-protein score that differentiates bacterial from viral infection: Analytical evaluation.Hainrichson, M., Avni, N., Eden, E., et al.[2023]
The MeMed BV (MMBV) diagnostic tool can effectively differentiate between bacterial and viral infections in suspected community-acquired pneumonia (CAP) patients, potentially reducing unnecessary antibiotic prescriptions.
Incorporating MMBV into standard care could lead to significant cost savings, averaging $37 per patient for payers and $223 for providers, by improving antibiotic stewardship and reducing hospital admissions and lengths of stay.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Cost impact analysis of novel host-response diagnostic for patients with community-acquired pneumonia in the emergency department.Schneider, JE., Cooper, JT.[2022]
A study involving 1217 females with suspected adverse events after HPV vaccination found that EBV infection around the time of vaccination is not a significant risk factor for these events, as only a small number had recent EBV infections.
The higher rates of EBV testing among those reporting adverse events suggest that the symptoms attributed to the vaccine may actually be due to other factors, rather than a direct link to the HPV vaccination.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Are unexplained adverse health events following HPV vaccination associated with infectious mononucleosis? - A Danish nationwide matched case-control study.Krogsgaard, LW., Helmuth, IG., Bech, BH., et al.[2021]
In a study of 636 bronchoalveolar lavage fluid samples, 30% tested positive for viruses, with immunosuppression and ground-glass attenuations on CT scans being significant predictors of positive results.
Viral testing on BAL fluid is most beneficial for immunocompromised patients with acute respiratory diseases or those showing unexplained ground-glass opacities, as PCR testing improved diagnostic yield by 50%.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Which patients should be tested for viruses on bronchoalveolar lavage fluid?Jouneau, S., Poineuf, JS., Minjolle, S., et al.[2021]
During an outbreak of respiratory syncytial virus type B (RSV-B) in a hematology/oncology unit, 19 cases were identified, including 14 patients and 5 healthcare workers, but all cases recovered without severe complications, indicating a lower virulence of RSV-B compared to other respiratory viruses.
Strict outbreak control measures were effective in halting the spread of RSV-B, highlighting the importance of vigilance and preventive strategies in high-risk healthcare settings to manage respiratory virus outbreaks.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Respiratory syncytial virus outbreak on an adult stem cell transplant unit.Kelly, SG., Metzger, K., Bolon, MK., et al.[2018]
In a study of 37 marrow transplant recipients, the presence of cytomegalovirus (CMV) in bronchoalveolar lavage (BAL) fluid was found to have a positive predictive value of only 43% for developing CMV pneumonia, indicating that a positive BAL result is not a strong indicator of future pneumonia risk.
CMV viremia (the presence of CMV in the blood) was identified as a significant risk factor for developing CMV pneumonia, with a positive predictive value of 66%, suggesting that monitoring blood for CMV may be more effective than relying solely on BAL results.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Prediction of cytomegalovirus pneumonia after marrow transplantation from cellular characteristics and cytomegalovirus culture of bronchoalveolar lavage fluid.Slavin, MA., Gooley, TA., Bowden, RA.[2019]
References
Validation of a multi-analyte immunoassay for distinguishing bacterial vs. viral infections in a pediatric cohort. [2023]
Cost-Impact Analysis of a Novel Diagnostic Test to Assess Community-Acquired Pneumonia Etiology in the Emergency Department Setting: A Multi-Country European Study. [2023]
A point-of-need platform for rapid measurement of a host-protein score that differentiates bacterial from viral infection: Analytical evaluation. [2023]
Cost impact analysis of novel host-response diagnostic for patients with community-acquired pneumonia in the emergency department. [2022]
What's new in bacterial vaginosis and trichomoniasis? [2005]
The v-safe after vaccination health checker: Active vaccine safety monitoring during CDC's COVID-19 pandemic response. [2023]
Characterization of the Differential Adverse Event Rates by Race/Ethnicity Groups for HPV Vaccine by Integrating Data From Different Sources. [2022]
Safety Surveillance of Varicella Vaccines in the Vaccine Adverse Event Reporting System, United States, 2006-2020. [2022]
Utility of a Laboratory Alert System for Detecting Adverse Drug Reactions in Hospitalised Patients: Hyponatremia and Rhabdomyolysis. [2022]
Are unexplained adverse health events following HPV vaccination associated with infectious mononucleosis? - A Danish nationwide matched case-control study. [2021]
Which patients should be tested for viruses on bronchoalveolar lavage fluid? [2021]
Rapid detection cytomegalovirus pneumonia in recipients of bone marrow transplant: evaluation and comparison of five survey methods for bronchoalveolar lavage fluid. [2013]
Respiratory syncytial virus outbreak on an adult stem cell transplant unit. [2018]
Prediction of cytomegalovirus pneumonia after marrow transplantation from cellular characteristics and cytomegalovirus culture of bronchoalveolar lavage fluid. [2019]
Diagnostic Performance of Multiplex Nucleic Acid Testing of Bronchoalveolar Lavage and Bronchial Wash Specimens for Respiratory Viral Pathogens. [2019]