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

Trial Summary

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 makes the MeMed BV Test unique for diagnosing pneumonia in children?

The MeMed BV Test is unique because it uses a novel approach to diagnose infections by analyzing the body's immune response, rather than directly detecting the pathogen (germ) itself, which can help distinguish between bacterial and viral infections more accurately. ^{1 2 3 4 5}

What is the purpose of this trial?

Children are commonly hospitalized because of community-acquired pneumonia. Despite the fact that many of these children have viral disease, a majority is treated with antibiotics. These antibiotics will not accelerate recovery in those with viral pneumonia and can cause harm. We are interested in exploring whether the MeMed BV - a composite biomarker assay - could be used to improve antibiotic prescribing in these children by identifying those who likely have viral disease. This proposal describes a feasibility randomized trial of this diagnostic intervention.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Dried blood spots PCR assays to screen congenital cytomegalovirus infection: a meta-analysis. [2018]

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

Bronchoscopic diagnosis of cytomegalovirus pneumonia following pediatric bone marrow transplantation. [2019]

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

Newborn Congenital Cytomegalovirus Screening Based on Clinical Manifestations and Evaluation of DNA-based Assays for In Vitro Diagnostics. [2017]

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

A rational approach to identifying newborns with hearing loss caused by congenital cytomegalovirus infection by dried blood spot screening. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Retrospective identification of congenital cytomegalovirus infection using dried blood samples - missed opportunities and lessons. [2022]