A COMBINATION OF AMOXICILLIN AND CLAVULANATE EVERY 12 HOURS VS EVERY 8 HOURS FOR TREATMENT OF ACUTE BACTERIAL MAXILLARY SINUSITIS

Objective: To compare the safety and efficacy of a combination of amox icillin and clavulanate potassium given orally every 12 hours (amoxici llin, 875 mg; clavulanate, 125 mg) with that given every 8 hours (amox icillin, 500 mg; clavulanate, 125 mg) for the treatment of patients wi th acute bacterial maxillary sinusitis. Design: Multicenter double-bli nd randomized double-dummy controlled trial. Setting: Physicians' offi ces and ambulatory care clinics. Patients: One hundred seventy patient s at least 18 years of age with acute bacterial maxillary sinusitis wh o could be treated with an oral antimicrobial agent were randomized, a nd data from 134 were suitable for evaluation. Four patients were with drawn from this study because of adl verse effects. Interventions: Pat ients received a combination of amoxicillin and clavulanate orally eve ry 12 hours (amoxicillin, 875 mg; clavulanate, 125 mg) or every 8 hour s (amoxicillin, 500 mg; clavulanate, 125 mg) for 14 days. Main Outcome Measure: Clinical success at the end of therapy. Results: Clinical su ccess at the end of therapy was similar for the 2 treatment groups, 93 % and 88% of patients in the every 12-hour and every 8-hour groups, re spectively (P=.76; 95% confidence interval, -4.0% to 15.6%). Clinical success rates at follow-up 2 to 4 weeks after the end of therapy were also similar in the 2 groups. Adverse events related to treatment were reported with similar frequency in the 2 groups. Conclusion: Amoxicil lin and clavulanate given every 12 hours is as effective and as safe a s administration every 8 hours for the treatment of acute bacterial ma xillary sinusitis.