A Trial of High‐Dose, Short‐Course Levofloxacin for the Treatment of Acute Bacterial Sinusitis

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Abstract
OBJECTIVES: Compare two dosage strengths of levofloxacin in the treatment of acute bacterial sinusitis.STUDY DESIGN AND SETTING: Multicenter clinical trial comparing levofloxacin 750 mg for 5 days vs levofloxacin 500 mg for 10 days.RESULTS: Sinus fluid samples were obtained by antral puncture (59.2%) or by sinus endoscopy (40.8%). Among microbiologically evaluable patients, 91.4% (139/152) of patients receiving levofloxacin 750 mg achieved clinical success vs 88.6% (132/149) of patients receiving levofloxacin 500 mg (95% CI −10.0, 4.2). Clinical success rates by pathogen were above 90% in both treatment groups for the 3 typical pathogens of acute sinusitis:Streptococcus pneumoniae, Haemophilus influenzae, andMoraxella catarrhalis. The safety profile of the 2 dosage strengths was similar.CONCLUSION: Levofloxacin 750 mg for 5 days is noninferior to levofloxacin 500 mg for 10 days.SIGNIFICANCE: Levofloxacin 750 mg for 5 days represents a safe and effective treatment regimen for acute bacterial sinusitis.EBM rating: A‐1b