A combination of amoxicillin and clavulanate every 12 hours vs every 8 hours for treatment of acute bacterial maxillary sinusitis.

Abstract

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 Four patients were withdrawn from this study because of adverse effects.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.

• Authors: J S Seggev, R R Enrique, M L Brandon, L S Larsen, R A Van Tuyl, C A Rowinski
• Journal: Archives of otolaryngology--head & neck surgery (Arch Otolaryngol Head Neck Surg) Vol. 124 Issue 8 Pg. 921-5 (Aug 1998) ISSN: 0886-4470 [Print] United States
• PMID: 9708721 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Clavulanic Acid
• Amoxicillin

Topics

• Acute Disease
• Administration, Oral
• Adult
• Aged
• Amoxicillin (administration & dosage, adverse effects)
• Bacterial Infections (drug therapy)
• Clavulanic Acid (administration & dosage, adverse effects)
• Double-Blind Method
• Drug Therapy, Combination (administration & dosage, adverse effects)
• Female
• Humans
• Male
• Maxillary Sinusitis (drug therapy)
• Middle Aged