MeMed BV + Usual Care: We will aim to have blood drawn for MeMed BV testing within 24 hours of the first dose of IV antibiotics. We will then aim to have test results back within 24 hours of sampling.
Usual Care Alone: Usual care can involve oxygenation support, ventilatory support, intravenous fluids, and antibiotics, or any combination of these.
Study summary
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
Sex
ALL
Min age
6 Months
Max age
18 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Consent success — Day 0 The proportion of potentially eligible participants who consent
MeMed BV test timing — before Day 2 The proportion of participants randomized to the diagnostic intervention who successfully have the MeMed BV performed within 24 h of receipt of the initial dose of IV antibiotics
MeMed BV test result reporting — before Day 3 The proportion of participants randomized to MeMed BV testing that have a test result available within 48h of sampling
MeMed BV test result initial adherence — before Day 4 The proportion of participants found to be high risk for viral infection that successfully have their antibiotics stopped within 24 hours of the test result becoming available
MeMed BV test result delayed adherence — before Day 15 The proportion of participants (who successfully had their antibiotics stopped) that do not have them restarted specifically for CAP treatment prior to discharge
Losses to followup — before Day 30 The proportion of participants lost to follow-up
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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