A randomised, open-label equivalency trial 1 on home treatment with high-dose oral amoxicillin for severe pneumonia in children was performed at seven study sites in Pakistan. 2037 children aged 3-59 months with severe pneumonia were allocated to either initial hospitalisation and parenteral ampicillin (100 mg/kg per day in four doses) for 48 h, followed by 3 days of oral amoxicillin (80-90 mg/kg per day; n=1012) or to home-based treatment for 5 days with oral amoxicillin (80-90 mg/kg per day in two doses; n=1025). Analyses were done per protocol and by intention to treat. There were 87 (8.6%) treatment failures (defined as clinical deterioration) in the hospitalised group and 77 (7.5%) in the ambulatory group (risk difference 1.1%; 95% CI -1.3 to 3.5) by day 6. Five (0.2%) children died within 14 days of enrollment, one in the ambulatory group and four in the hospitalised group. In each case, treatment failure was declared before death and the antibiotic had been changed. None of the deaths were considered to be associated with treatment allocation.
Comment: The quality of evidence is downgraded by limitations in study quality (possible allocation and surveillance bias).
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