Randomized controlled double-blind non-inferiority clinical trial to determine whether five days of high-dose amoxicillin leads to comparable rates of early clinical cure compared with 10 days of high-dose amoxicillin for previously healthy children with mild community-acquired pneumonia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
281
Experimental arm must receive 5 days placebo after 5 days amoxicillin to preserve blinding.
McMaster Children's Hospital
Hamilton, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Early clinical cure (Resolution of tachypnoea, increased work of breathing, and fever)
Resolution of tachypnoea, increased work of breathing, and fever
Time frame: at 14-21 days post-enrolment
Days of adverse reactions
Time frame: up to 14 days post-enrolment
Days of missed school
Time frame: up to 14 days post-enrolment
Days of missed/disrupted work for caregiver(s)
Time frame: up to 14 days post-enrolment
Adherence to study medications
Time frame: up to 10 days post-enrolment
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