Children are commonly hospitalized because of community-acquired pneumonia (CAP). There are multiple high-quality randomized trials of short-course antibiotic therapy (3-5 days of treatment) for adults hospitalized with CAP - but there is very little evidence in children. We intend to do a pilot RCT of short-course (3-5 days) vs standard-duration (8-10 days) antibiotic therapy for children hospitalized for CAP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
75
5 days of placebo to be given after 3-5 days of antibiotics
Standard-dose amoxicillin (approved by Health Canada) to be given x 5 days.
McMaster Children's Hospital
Hamilton, Ontario, Canada
RECRUITINGConsent success
The proportion of potentially eligible participants who consent
Time frame: Day 0
Open-label antibiotic use
The proportion of participants who receive open-label (non-study) antibiotics
Time frame: before Day 30
Losses to followup
The proportion of participants lost to follow-up
Time frame: before Day 30
Proportion of participants with late clinical response
LCR is defined as: i) clinical improvement in fever, work of breathing, oral intake, and activity level, AND ii) lack of receipt of additional antimicrobials
Time frame: Day 15
Proportion of participants with repeat hospitalization for CAP
Time frame: before Day 30
Proportion of participants with drug-related AEs (any severity)
Time frame: before Day 30
Proportion of participants with serious drug AEs
Time frame: before Day 30
Proportion of participants with unscheduled ED or urgent care visits
Time frame: before Day 30
Proportion of participants with unscheduled primary care visits
Time frame: before Day 30
Proportion of participants who develop complicated pneumonia
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Complicated defined by effusion, empyaema, necrotizing pneumonia
Time frame: before Day 30