MeMed BV Test for Respiratory Infection

Recruiting at 11 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MeMed Diagnostics Ltd.

Must not be taking: Antibiotics, Steroids, Immunosuppressants, others

Disqualifiers: Inflammatory disease, Immune deficiency, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Not specified

1316 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new test called MeMed BV, which helps doctors determine if antibiotics are necessary for individuals with symptoms of a lower respiratory infection, such as a severe cough or difficulty breathing. The trial aims to assess whether using this test can improve patient outcomes and reduce unnecessary antibiotic use. Participants will be divided into two groups: one will use the MeMed BV test to guide treatment, while the other will receive standard care without the test. This trial suits adults who have developed symptoms like a new or worsening cough or shortness of breath within the last week and have not recently taken antibiotics. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance future treatment strategies.

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.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken systemic antibiotics within 72 hours before joining. If you are on immune-suppressive or immune-modulating therapies, you may not be eligible.

What prior data suggests that the MeMed BV test is safe for use in diagnosing respiratory infections?

Research has shown that the MeMed BV test is safe for people. This test helps doctors determine whether an infection is bacterial or viral by analyzing the body's immune response. The FDA has approved it, confirming it meets safety standards set by health authorities. Studies have not identified any negative side effects from using the test, indicating it is well-tolerated by those who have taken it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for lower respiratory tract infections, which typically rely on broad-spectrum antibiotics, the MeMed BV test offers a unique approach by providing a rapid diagnostic tool that can help determine whether an infection is bacterial or viral. This distinction is crucial because it guides clinicians in deciding whether antibiotics are necessary, potentially reducing the misuse of antibiotics and helping to combat antibiotic resistance. Researchers are excited about this trial because it could lead to more precise and personalized treatment plans, improving patient outcomes and preserving antibiotic effectiveness for the future.

What evidence suggests that the MeMed BV test is effective for lower respiratory infections?

Research has shown that the MeMed BV test, which participants in this trial may receive, can accurately distinguish between bacterial and viral infections. One study found that it correctly identified 86.7% of people with bacterial infections and 91.1% of those without. This accuracy helps determine who needs antibiotics, which only work on bacterial infections, not viral ones. By using the MeMed BV test, doctors can make better decisions and potentially improve patient care. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Pre-study Implementation

Participating clinicians become familiar with the MeMed BV test and test design and operational assumptions

Not specified

Screening

Participants are screened for eligibility to participate in the trial

Not specified

Treatment

Participants receive either the MeMed BV test result with antibiotic recommendation or standard care without the test result

Not specified

Follow-up

A telephone follow-up call is conducted at 28 (+/- 3) days after consent to complete a short questionnaire regarding the current illness

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MeMed BV test

Trial Overview The 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.

How Is the Trial Designed?

Group I: Adults with suspected Lower Respiratory Track Infection (LRTI)- The MeMed BV arm Experimental Treatment 1 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 arm Active Control 1 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

MeMed BV test is already approved in United States, European Union for the following indications:

Approved in United States as MeMed BV for:

• Differentiation between bacterial and viral infections in patients presenting to the emergency department or urgent care center

Approved in European Union as LIAISON MeMed BV for:

• Differentiation between bacterial and viral infections

Who Is Running the Clinical Trial?

MeMed Diagnostics Ltd.

Lead Sponsor

Trials

17

Recruited

14,700+

Published Research Related to This Trial

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]

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]

The v-safe program, developed by the CDC, monitored the safety of COVID-19 vaccines by collecting over 131 million health check-in surveys from 9.3 million participants, providing real-time data on post-vaccination experiences.

The program not only assessed vaccine safety but also facilitated enrollment in a pregnancy registry to evaluate maternal and infant outcomes, demonstrating its potential for future vaccine monitoring and pandemic responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The v-safe after vaccination health checker: Active vaccine safety monitoring during CDC's COVID-19 pandemic response. Myers, TR., Marquez, PL., Gee, JM., et al.[2023]

This study introduces a new statistical method that combines data from the Vaccine Adverse Event Reporting System (VAERS) with CDC survey and U.S. census data to analyze adverse event rates for the HPV vaccine across different racial and ethnic groups.

The analysis revealed that there are 9 adverse events with significantly different reporting rates between non-Hispanic White females and other racial/ethnic groups, highlighting the importance of considering demographic factors in vaccine safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of the Differential Adverse Event Rates by Race/Ethnicity Groups for HPV Vaccine by Integrating Data From Different Sources. Huang, J., Du, J., Duan, R., et al.[2022]

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]

New molecular microbiologic techniques are enhancing our understanding of bacterial vaginosis (BV) and identifying different subgroups of women with varying risks for complications.

Emerging diagnostic tests may enable women to self-test for BV, and innovative treatment methods are showing promise in managing recurrent cases of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What's new in bacterial vaginosis and trichomoniasis? Sobel, JD.[2005]

A study involving 170 patients and 184 respiratory specimens showed that multiplex nucleic acid testing (NAT) on bronchial wash (BW) specimens had a higher positive agreement (95.0%) compared to bronchoalveolar lavage (BAL) specimens (85.0%), indicating BW may be more effective for detecting respiratory pathogens.

The overall concordance between NAT results from BAL and BW specimens was very high at 95%, suggesting that both specimen types are reliable for pathogen detection, but the additional testing may need to be weighed against potential complications and costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Performance of Multiplex Nucleic Acid Testing of Bronchoalveolar Lavage and Bronchial Wash Specimens for Respiratory Viral Pathogens. Munigala, S., Burnham, CA., Anderson, NW., et al.[2019]

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]

In a study of 43 bone marrow transplant recipients, PCR testing was the most sensitive method for detecting cytomegalovirus-associated interstitial pneumonia (CMV-IP), identifying 12 cases, while shell vial and culture methods also showed effectiveness.

Patients identified with the highest risk of CMV-IP (Group 1) were successfully treated with a combination of ganciclovir and immunoglobulin, demonstrating the importance of early detection for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid detection cytomegalovirus pneumonia in recipients of bone marrow transplant: evaluation and comparison of five survey methods for bronchoalveolar lavage fluid. Goto, H., Yuasa, K., Sakamaki, H., et al.[2013]

From 2006 to 2020, the single-antigen varicella vaccine (VAR) and the combination measles, mumps, rubella, and varicella vaccine (MMRV) showed favorable safety profiles, with serious adverse events reported at rates of 1.3 per 100,000 doses for both vaccines.

The most common adverse events were mild, such as injection site reactions and fever, and no new or unexpected safety issues were identified, reinforcing the vaccines' safety when administered as recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Surveillance of Varicella Vaccines in the Vaccine Adverse Event Reporting System, United States, 2006-2020. Moro, PL., Leung, J., Marquez, P., et al.[2022]

A laboratory alert system was evaluated for detecting adverse drug reactions (ADRs) in hospitalized patients, showing that the hyponatremia alert identified ADRs in 39.3% of cases, significantly more than the 3.3% found with the rhabdomyolysis alert.

The study suggests that using automated laboratory signals for pharmacovigilance can effectively detect ADRs, with the hyponatremia alert being more efficient, identifying 12 times more ADRs than the rhabdomyolysis alert, thus saving time in the evaluation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of a Laboratory Alert System for Detecting Adverse Drug Reactions in Hospitalised Patients: Hyponatremia and Rhabdomyolysis. Valdés-Garicano, M., Mejía-Abril, G., Campodónico, D., et al.[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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05762302

Study Details | NCT05762302 | The Impact of MeMed BV® ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12469186/

Real-World Utility of the Host-Response MeMed BV Test in ... In the OPPORTUNITY study, MMBV achieved 86.7% sensitivity and 91.1% specificity in differentiating bacterial from viral infections in children ...

3. publications.aap.org publications.aap.org/hospitalpediatrics/article/14/11/881/199625/The-Association-of-the-MeMed-BV-Test-With

The 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.

4. sciencedirect.com sciencedirect.com/science/article/pii/S120197122500267X

Diagnostic Accuracy of a Host Response Test in Suspected ... Christian, et al. MeMed BV testing in emergency department patients presenting with febrile illness concerning for respiratory tract infection.

5. ctv.veeva.com ctv.veeva.com/study/the-impact-of-memed-bv-r-on-management-of-patients-with-suspected-lower-respiratory-tract-infections

The Impact of MeMed BV® on Management of Patients With ... 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 ...

6. beckmancoulter.com beckmancoulter.com/products/immunoassay/memed-bv

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 ...

7. academic.oup.com academic.oup.com/ofid/article/12/Supplement_1/ofae631.2399/7988605

P-2246. Diagnostic Performance of a Rapid Host-Protein Test ... MeMed BV® is a rapid, FDA-cleared, host-protein test to differentiate bacterial and viral infection, with sensitivity and specificity >90%, ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/acem.70031

Effect of host‐protein test (TRAIL/IP‐10/CRP) on antibiotic ... Additionally, we observed that MeMed BV reduced unnecessary antibiotic prescriptions in patients with viral MeMed BV scores presenting to the ED ...