Improving care for children with pneumonia using new diagnostic tools

Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: a Feasibility Randomized Controlled Trial of a Diagnostic Intervention

This study is testing a new test to see if it can help doctors better treat children with pneumonia by identifying those who don’t need antibiotics, so they can avoid giving unnecessary medication.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 6 Months to 18 Years
• Sex: All
• Sponsor: McMaster University (other)
• Locations: 1 site (Hamilton, Ontario)
• Trial ID: NCT06114888 on ClinicalTrials.gov

What this trial studies

This study aims to optimize the treatment of children hospitalized with community-acquired pneumonia (CAP) by evaluating the effectiveness of the MeMed BV biomarker assay. The trial will compare the outcomes of children receiving the MeMed BV test alongside usual care versus those receiving usual care alone. The goal is to identify children with viral pneumonia who do not require antibiotics, thereby reducing unnecessary antibiotic use and potential harm. This feasibility randomized trial will help determine if the biomarker can improve antibiotic prescribing practices in pediatric patients.

Who should consider this trial

Good fit: Ideal candidates for this study are children hospitalized with severe community-acquired pneumonia who exhibit specific clinical signs and have abnormal chest imaging.

Not a fit: Patients who have received more than 48 hours of intravenous antibiotics or have significant bacterial infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate diagnoses and reduced antibiotic use in children with pneumonia, minimizing unnecessary treatments and side effects.

How similar studies have performed: Other studies have shown promise in using biomarker assays for diagnosing pneumonia, suggesting potential success for this novel approach.

Eligibility criteria

Inclusion Criteria:

* children with a history of fever who are hospitalized with CAP (ie. 'severe CAP') as per the clinical team and who have abnormal chest imaging (eg. radiograph, ultrasound) will be eligible. They must also have at least one of the following:

  1. documented tachypnoea (\>60 bpm for age \<1 y, \>50 bpm for 1-2 y, \>40 bpm for 2-4 y, and \>30 bpm for \>4 y);
  2. cough on exam or by history;
  3. increased work of breathing on exam; or
  4. auscultatory findings (eg. focal crackles, bronchial breathing) consistent with CAP.

Exclusion Criteria:

* Children will be excluded from if they have received \>48h of intravenous antibiotics (eg. if transferred from another healthcare facility) or if they have a lobar consolidation that occupies the majority of a lobe on imaging, a pleural effusion that occupies more than ¼ of a lung field, or a positive blood culture for a bacterial pathogen (not a contaminant). Examples of CAP pathogens include S. pneumoniae, S. pyogenes (group A streptococcus), S. aureus, S. anginosus. Examples of contaminants that would be ignored include the coagulase-negative staphylococci and Bacillus spp. Children will also be excluded if they have any of the following: chronic lung disease, congenital heart disease (requiring treatment or with exercise restrictions), malignancy, immunodeficiency (primary, acquired, or iatrogenic), a separate episode of pneumonia previously diagnosed within the past 2 weeks, or lung abscess diagnosed within the past six months. Children will not be eligible to participate more than once.

Where this trial is running

Hamilton, Ontario

• McMaster Children's Hospital — Hamilton, Ontario, Canada (RECRUITING)

Study contacts

• Study coordinator: Jeffrey Pernica, MD

Conditions: Community-acquired Pneumonia