Outcomes
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SECONDARY
The coprimary outcomes measured at the individual patient level included: (1) antibiotic prescription at the time of the initial consultation as documented by the health-care provider (superiority analysis); and (2) clinical failure at day 7 defined as ‘not cured’ and ‘not improved’, or unscheduled hospitalization as reported by caregivers (noninferiority analysis). Secondary outcomes include unscheduled reattendance visits at any health facility by day 7, nonreferred secondary hospitalization by day 7, death by day 7 and referral for inpatient hospitalization at initial consultation. Additional antibiotics prescribed on subsequent days following the initial consultation were not part of the coprimary outcome of antibiotic prescription; instead this is captured by phone call on day 7, where all patients are assessed for whether additional medication was taken after the initial consultation, and compared between study arms as an exploratory outcome. Given patients’ and caregivers’ difficulty in distinguishing antibiotics from other medications