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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
75
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 can involve oxygenation support, ventilatory support, intravenous fluids, and antibiotics, or any combination of these.
McMaster Children's Hospital
Hamilton, Ontario, Canada
RECRUITINGConsent success
The proportion of potentially eligible participants who consent
Time frame: Day 0
MeMed BV test timing
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
Time frame: before Day 2
MeMed BV test result reporting
The proportion of participants randomized to MeMed BV testing that have a test result available within 48h of sampling
Time frame: before Day 3
MeMed BV test result initial adherence
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
Time frame: before Day 4
MeMed BV test result delayed adherence
The proportion of participants (who successfully had their antibiotics stopped) that do not have them restarted specifically for CAP treatment prior to discharge
Time frame: before Day 15
Losses to followup
The proportion of participants lost to follow-up
Time frame: before Day 30
Early clinical response
This is defined as: i) clinical improvement in fever, work of breathing, oral intake, and activity level, AND ii) lack of receipt of additional antimicrobials beyond those already being given at baseline (for the control group) or as indicated by MeMed BV testing (for those randomized to the intervention group)
Time frame: Day 4
Days of antibiotics given specifically for CAP before hospital discharge
Time frame: Before discharge
Days of antibiotics given specifically for CAP after hospital discharge and before day 30
Time frame: after hospital discharge and before day 30
Time to resolution of fever
Time frame: Before discharge
Time to resolution of difficulty breathing
Time frame: Before discharge
Time to resolution of hypoxaemia
Time frame: Before discharge
Length of stay in hospital
Time frame: Before discharge
Repeat hospitalization for CAP
Time frame: After discharge and before day 30
Unscheduled ED or urgent care visits
Time frame: After discharge and before day 30
Unscheduled primary care visits
Time frame: After discharge and before day 30
Development of complicated pneumonia
Complicated defined by effusion, empyaema, necrotizing pneumonia
Time frame: Before Day 30
Acceptability of care plan to caregiver
Time frame: Baseline
Acceptability of care plan to caregiver
Time frame: Day 30
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