Novel Diagnostics for Pneumonia in Children

(PRESTO-1 Trial)

Overseen By Shamini Selvakumar, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Jeffrey

Disqualifiers: Chronic lung disease, Congenital heart disease, Malignancy, Immunodeficiency, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 days

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called MeMed BV to help doctors determine if antibiotics are necessary for children with severe pneumonia. Many children with pneumonia may actually have a viral infection, meaning antibiotics won't help and could cause harm. The goal is to see if MeMed BV can better identify viral cases so antibiotics are given only when truly needed. Eligible children have been hospitalized with pneumonia, have a fever, and show signs like fast breathing or a cough. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve treatment decisions for children with pneumonia.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to consult with the trial coordinators for specific guidance.

What prior data suggests that the MeMed BV diagnostic test is safe for children?

Research shows that the MeMed BV test helps doctors determine whether an infection is bacterial or viral by examining specific proteins in the immune system. This test aids doctors in deciding if antibiotics are necessary.

Studies have found that MeMed BV accurately identifies bacterial infections, preventing unnecessary antibiotic use for viral infections—a significant advantage. As a diagnostic tool rather than a medication, no evidence suggests harmful effects from its use.

The MeMed BV test, focused on improving diagnosis, is considered safe. No reports of negative effects exist since it doesn't involve taking a new drug. Instead, it assists doctors in making more accurate treatment decisions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MeMed BV because it offers a new approach to diagnosing pneumonia in children quickly and accurately. Traditional methods, like chest X-rays or blood tests, can be slow or inconclusive. MeMed BV stands out because it uses a unique protein-signature technology that analyzes the immune response to distinguish between bacterial and viral infections. This rapid and precise diagnostic tool could lead to faster, more targeted treatments, potentially reducing the overuse of antibiotics and improving patient outcomes.

What evidence suggests that the MeMed BV test is effective for improving antibiotic prescribing in children with pneumonia?

In this trial, participants will receive either usual care or the MeMed BV test, which researchers are studying for its ability to distinguish between bacterial and viral infections, particularly in the lungs. Research has shown that the MeMed BV test accurately identifies bacterial infections. Specifically, in studies, children whom the MeMed BV test indicated had a higher chance of bacterial infection were more likely to have pneumonia visible on X-rays. The test performs well in diagnosing community-acquired bacterial pneumonia but is less accurate for viral infections. Overall, MeMed BV could help reduce unnecessary antibiotic use by identifying viral infections in children. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for children hospitalized with community-acquired pneumonia who show signs like fast breathing, coughing, and difficulty in breathing or specific sounds in their lungs. It's not suitable for those who don't meet the breathing rate criteria or other specified conditions.

Inclusion Criteria

I have symptoms like fast breathing, coughing, or signs of lung infection.

My child has severe pneumonia, confirmed by a fever and abnormal chest scans.

Exclusion Criteria

My child has had a serious lung infection treated with IV antibiotics for more than 2 days.

My child has been part of this study before.

My child has a chronic lung or heart condition, cancer, immune issues, recent pneumonia, or a recent lung abscess.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either usual care or the MeMed BV diagnostic intervention to guide antibiotic prescribing

4 days

Daily monitoring during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of early clinical response and losses to follow-up

30 days

Extension

Participants are monitored for the development of complicated pneumonia

30 days

What Are the Treatments Tested in This Trial?

Interventions

• MeMed BV

Trial Overview The study tests if using MeMed BV (a test that helps determine if an infection is viral) along with usual care can improve antibiotic use compared to just usual care. The goal is to see if this approach reduces unnecessary antibiotic treatment.

How Is the Trial Designed?

Group I: MeMed BV Experimental Treatment 1 Intervention

Group II: Usual Care Active Control 1 Intervention

MeMed BV is already approved in United States for the following indications:

Approved in United States as MeMed BV Test for:

• Aiding in the identification of bacterial and viral infections in pediatric and adult patients presenting to emergency departments or urgent care centers with symptoms lasting less than seven days.

Who Is Running the Clinical Trial?

Jeffrey

Lead Sponsor

Trials

2

Recruited

150+

Jeffrey Pernica

Lead Sponsor

Trials

3

Recruited

230+

Published Research Related to This Trial

A newly developed dried blood spot (DBS)-based assay using real-time quantitative PCR (qPCR) demonstrated a sensitivity of 83% and specificity of 97% for detecting congenital cytomegalovirus (cCMV) infection in a study of 9,675 newborns.

The study found that DBS screening for cCMV is a feasible and effective method for mass screening, with a very high recovery rate of 99.92%, suggesting it could be implemented in clinical settings to identify at-risk newborns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A rational approach to identifying newborns with hearing loss caused by congenital cytomegalovirus infection by dried blood spot screening. Moteki, H., Isaka, Y., Inaba, Y., et al.[2018]

Out of 436 children born with congenital cytomegalovirus (cCMV), only 19 (4.4%) were diagnosed using dried blood-spot PCR testing, highlighting significant missed opportunities for early detection.

Universal newborn screening for cCMV could have potentially prevented long-term issues, such as severe hearing loss and developmental delays, in 8 out of the 19 diagnosed children, suggesting that early diagnosis is crucial for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective identification of congenital cytomegalovirus infection using dried blood samples - missed opportunities and lessons. Shahar-Nissan, K., Oikawa Tepperberg, M., Mendelson, E., et al.[2022]

A risk-based screening strategy for congenital cytomegalovirus (cCMV) in newborns was found to be at least 10 times more effective in identifying cases compared to previous universal screening methods, although it may miss some asymptomatic infections.

The urine-filter-based assay, along with confirmatory diagnostic tests, proved to be an efficient method for detecting cCMV cases, highlighting the importance of using multiple diagnostic approaches for accurate identification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Newborn Congenital Cytomegalovirus Screening Based on Clinical Manifestations and Evaluation of DNA-based Assays for In Vitro Diagnostics. Fujii, T., Oka, A., Morioka, I., et al.[2017]

A meta-analysis of 15 studies involving 26,007 neonates found that dried blood spots (DBS) PCR assays for screening congenital cytomegalovirus (cCMV) infection have a high specificity of 99.9% and a sensitivity of 84.4%.

While the DBS PCR assay is highly accurate, it is more effective for retrospective diagnosis of cCMV rather than as a primary screening tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dried blood spots PCR assays to screen congenital cytomegalovirus infection: a meta-analysis. Wang, L., Xu, X., Zhang, H., et al.[2018]

A pediatric patient who underwent a bone marrow transplant developed cytomegalovirus (CMV) pneumonia, diagnosed using flexible fiberoptic bronchoscopy and bronchoalveolar lavage (BAL).

The study highlights the effectiveness of BAL as a diagnostic tool for CMV pneumonitis in immunocompromised children, emphasizing its importance in managing post-transplant complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bronchoscopic diagnosis of cytomegalovirus pneumonia following pediatric bone marrow transplantation. McCray, PB., Wagener, JS., Howe, CW.[2019]

Citations

1. 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.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39397543/

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.

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

Diagnostic Accuracy of a Host Response Test in Suspected ... MeMed BV® demonstrates good performance in diagnosing bacterial CAP infections. •. Low specificity for viral infections, particularly for SARS- ...

4. nature.com nature.com/articles/s41598-025-20208-1

A new biomarker combination differentiates viral from ... The MeMed BV® test showed a high sensitivity and specificity in distinguishing bacterial from viral LRTIs outperforming routine parameters, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11836884/

Host-response testing with MeMed BV in community- ... This test, called MeMed BV (MMBV), has demonstrated good diagnostic accuracy for differentiating bacterial from viral infections in multiple ...

6. 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 ...

7. me-med.com me-med.com/memed-bv/

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, ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2688115225002036

A Host-Protein Test for Differentiating Bacterial From Viral ... MeMed BV (MMBV), a blood test that measures 3 immune system proteins, helps physicians determine whether an infection is bacterial or viral. This study shows ...

9. researchgate.net researchgate.net/publication/384899588_The_Association_of_the_MeMed_BV_Test_With_Radiographic_Pneumonia_in_Children

The Association of the MeMed BV Test With Radiographic ... CONCLUSIONS Children with moderate to high likelihoods of bacterial infection on the BV test had higher odds of radiographic pneumonia. Apart from antibiotic ...