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

Trial Summary

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 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. ^{1 2 3 4 5}

What data supports the effectiveness of the MeMed BV test for respiratory infections?

Research shows that the MeMed BV test can accurately tell the difference between bacterial and viral infections by measuring specific proteins in the body. This helps doctors decide the right treatment, especially in cases like community-acquired pneumonia, where it's hard to tell the cause of the infection. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

Is the MeMed BV test a promising treatment for respiratory infections?

Yes, the MeMed BV test is promising because it helps quickly and accurately identify respiratory infections, which can lead to better and faster treatment decisions. ^{11 12 13 14 15}

What makes the MeMed BV test unique for diagnosing respiratory infections?

The MeMed BV test is unique because it uses a novel approach to distinguish between bacterial and viral infections by analyzing the host's immune response, rather than directly detecting the pathogens themselves. This can help guide appropriate treatment decisions, reducing unnecessary antibiotic use. ^{11 12 13 14 15}

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.

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.

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Validation of a multi-analyte immunoassay for distinguishing bacterial vs. viral infections in a pediatric cohort. [2023]

2. Switzerland 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. [2023]

3. United States 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Cost impact analysis of novel host-response diagnostic for patients with community-acquired pneumonia in the emergency department. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

What's new in bacterial vaginosis and trichomoniasis? [2005]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The v-safe after vaccination health checker: Active vaccine safety monitoring during CDC's COVID-19 pandemic response. [2023]

7. Switzerland 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Safety Surveillance of Varicella Vaccines in the Vaccine Adverse Event Reporting System, United States, 2006-2020. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Utility of a Laboratory Alert System for Detecting Adverse Drug Reactions in Hospitalised Patients: Hyponatremia and Rhabdomyolysis. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Are unexplained adverse health events following HPV vaccination associated with infectious mononucleosis? - A Danish nationwide matched case-control study. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

Which patients should be tested for viruses on bronchoalveolar lavage fluid? [2021]

12. England 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. [2013]

13. United States pubmed.ncbi.nlm.nih.gov

Respiratory syncytial virus outbreak on an adult stem cell transplant unit. [2018]

14. United States pubmed.ncbi.nlm.nih.gov

Prediction of cytomegalovirus pneumonia after marrow transplantation from cellular characteristics and cytomegalovirus culture of bronchoalveolar lavage fluid. [2019]

15. United States pubmed.ncbi.nlm.nih.gov

Diagnostic Performance of Multiplex Nucleic Acid Testing of Bronchoalveolar Lavage and Bronchial Wash Specimens for Respiratory Viral Pathogens. [2019]