Efficacy of twice-daily amoxycillin/clavulanate ('Augmentin-Duo' 400/57) in mild to moderate lower respiratory tract infection in children.

A new amoxycillin/clavulanate regimen ('Augmentin-Duo' 400/57), to be given orally in two divided doses, has been proposed to overcome the inconvenience of tid dosing. This observer-blind, multicentre study randomised children aged two to 12 years with lower respiratory tract infection to seven days' treatment with either amoxycillin/clavulanate bid at a dose of 25/3.6mg/kg/day (221 patients) or the currently prescribed amoxycillin/clavulanate regimen of 20/5mg/kg/day tid (216 patients). Clinical success (cure) rates at follow up were 81.0% for the bid group and 77.8% for the tid group [difference 3.2%; 95% CI (-4.36, 10.80)], indicating that the regimens were of equivalent efficacy. Both regimens were well tolerated, and there was no statistically significant difference in the incidence of adverse experiences between the two groups. Compliance with study medication was high and similar for both groups (80% compliance: bid 90.0%; tid 87.0%).