Dosing of Amoxicillin/Clavulanate Given Every 12 Hours Is as Effective as Dosing Every 8 Hours for Treatment of Lower Respiratory Tract Infection

In this double-blind study, 557 patients with lower respiratory tract infection were randomly assigned to receive amoxicillin/clavulanate orally either every 12 hours (875/125 mg) or every 8 hours (500/125 mg) for 7 – 15 days. For the 455 patients evaluable for clinical efficacy at the end of therapy, clinical success was similar in the two groups: 93% and 94% in the 12-hour and 8-hour groups, respectively (P = .42). Bacteriologic success at the end of therapy was also comparable: 97% and 91% in the 12-hour and 8-hour groups, respectively (P = .86). The occurrence of adverse events related to treatment was similar for the two groups, but fewer patients in the 12-hour group reported moderate or severe diarrhea. Amoxicillin/clavulanate (875/125 mg) given every 12 hours is as effective and safe as every-8-hours administration of the combination (500/125 mg) for the treatment of lower respiratory tract infection.