McMaster Children's Hospital
Hamilton, Ontario, L8S 4K1, Canada
Location status: Recruiting
NCT Number: NCT06114888
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.
Interested in participating?
Request Info6 month–18 year
All sexes
Interventional
Not applicable
Hamilton, Ontario, L8S 4K1, Canada
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 0
The proportion of potentially eligible participants who consent
Time frame: 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
Time frame: before Day 3
The proportion of participants randomized to MeMed BV testing that have a test result available within 48h of sampling
Time frame: 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
Time frame: 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
Time frame: before Day 30
The proportion of participants lost to follow-up
Time frame: Day 4
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: Before discharge
Time frame: after hospital discharge and before day 30
Time frame: Before discharge
Time frame: Before discharge
Time frame: Before discharge
Time frame: Before discharge
Time frame: After discharge and before day 30
Time frame: After discharge and before day 30
Time frame: After discharge and before day 30
Time frame: Before Day 30
Complicated defined by effusion, empyaema, necrotizing pneumonia
Time frame: Baseline
Time frame: Day 30
Contact information is provided by the study sponsor or research team.
Jeffrey
Other
Optimizing Care for Children Hospitalized With Community-acquired Pneumonia: a Feasibility Randomized Controlled Trial of a Diagnostic Intervention
Acronym: PRESTO-1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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