This Article  • Full text  • PDF  • Reply to article  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citing articles on ISI (5)  • Contact me when this article is cited  Related Content  • Similar articles in this journal  Topic Collections  • Drug Therapy  • Drug Therapy, Other  • Alert me on articles by topic

Joram S. Seggev, MD; Ronel R. Enrique, MD; Milan L. Brandon, MD; L. Scott Larsen, MD; Ronald A. Van Tuyl, MD; Carolyn A. Rowinski, PharmD; and the Acute Bacterial Maxillary Sinusitis Collaborative Study Group

Arch Otolaryngol Head Neck Surg. 1998;124:921-925.

Objective  To compare the safety and efficacy of a combination of amoxicillin and clavulanate potassium given orally every 12 hours (amoxicillin, 875 mg; clavulanate, 125 mg) with that given every 8 hours (amoxicillin, 500 mg; clavulanate, 125 mg) for the treatment of patients with acute bacterial maxillary sinusitis.

Design  Multicenter double-blind randomized double-dummy controlled trial.

Setting  Physicians' offices and ambulatory care clinics.

Patients  One hundred seventy patients at least 18 years of age with acute bacterial maxillary sinusitis who could be treated with an oral antimicrobial agent were randomized, and data from 134 were suitable for evaluation. Four patients were withdrawn from this study because of adverse effects.

Interventions  Patients received a combination of amoxicillin and clavulanate orally every 12 hours (amoxicillin, 875 mg; clavulanate, 125 mg) or every 8 hours (amoxicillin, 500 mg; clavulanate, 125 mg) for 14 days.

Main Outcome Measure  Clinical success at the end of therapy.

Results  Clinical success 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, respectively (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  Amoxicillin and clavulanate given every 12 hours is as effective and as safe as administration every 8 hours for the treatment of acute bacterial maxillary sinusitis.

From the Department of Internal Medicine, University of Nevada School of Medicine, Las Vegas (Dr Seggev); Piedmont Health Care, Statesville, NC (Dr Enrique); California Research Foundation, San Diego (Dr Brandon); Emergency Medical Offices, Clinical Research Division, Middletown, NJ (Dr Larsen); Insite Clinical Trials, Atlanta, Ga (Dr Van Tuyl); and SmithKline Beecham Pharmaceuticals, Collegeville, Pa (Dr Rowinski).