Efficacy of levofloxacin 750 mg for 5-days in the treatment of acute maxillary sinusitis: A randomized, double-blind study

RATIONALE: To demonstrate that a 5-day oral (p.o.) course of levofloxacin 750 mg once daily (q.d.) is at least as effective, both clinically and microbiologically, as a 10-day course of levofloxacin 500 mg p.o. q.d. in the treatment of acute maxillary sinusitis. METHODS: This was a multicenter, randomized, double-blind, non-inferiority study involving outpatient adults with acute bacterial maxillary sinusitis. Specimen for Gram's stain and culture susceptibility were obtained either by maxillary sinus puncture (59.2%) or sinus endoscope (40.8%). Subjects were randomized 1:1 to receive either 750 mg or 500 mg of levofloxacin. The primary efficacy outcome was clinical success (cure or improved) at Test-of-Cure visit among the microbiologically evaluable subjects. RESULTS: A total of 780 subjects were enrolled and received at least one dose of medication. In the 750 mg group, 152/389 (39.1%) subjects were microbiologically evaluable compared with 149/391 (38.1%) subjects in the 500 mg group. The clinical success rate in each group was 91.4% and 88.6%, respectively; 95% CI (−10.0, 4.2). Microbiologic eradication/presumed eradication rates for subjects' infection were 92.1% and 89.3%, respectively; 95% CI (−9.7, 4.1). No new or unexpected adverse events were seen among subjects in either treatment group. CONCLUSIONS: Oral levofloxacin 750 mg administered daily for 5 days was at least as effective and well-tolerated as 500 mg daily for 10 days for acute maxillary sinusitis.