OBJECTIVE: To compare the efficacy and safety of a single 2.0-g dose of a novel azithromycin microsphere formulation with that of 10 days of levofloxacin, 500 mg/d, when used to treat adults with uncomplicated acute bacterial maxillary sinusitis (ABS). STUDY DESIGN AND SETTING: An international, multicenter, randomized, double-blind, double-dummy trial. Eligible outpatients > or =18 years of age with clinical and radiographic evidence of ABS underwent maxillary sinus aspiration before randomization. Primary endpoint was clinical efficacy at the test-of-cure visit (day 17-24). RESULTS:Clinical success rates were 94.5% (242/256) in azithromycin-microspheres-treated patients and 92.8% (233/251) in the levofloxacin group. In patients with documented Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis, clinical cure rates were 97.3% (36/37), 96.3% (26/27), and 100% (8/8), respectively, for the azithromycin group and 92.3% (36/39), 100% (30/30), and 90.9% (10/11), respectively, for the levofloxacin group. CONCLUSIONS: Single-dose azithromycin microspheres provided clinical and bacteriologic efficacy and safety comparable to 10 days of levofloxacin. SIGNIFICANCE: A novel microsphere formulation of azithromycin given as a single dose was safe and effective for the treatment of ABS.
RCT Entities:
OBJECTIVE: To compare the efficacy and safety of a single 2.0-g dose of a novel azithromycin microsphere formulation with that of 10 days of levofloxacin, 500 mg/d, when used to treat adults with uncomplicated acute bacterial maxillary sinusitis (ABS). STUDY DESIGN AND SETTING: An international, multicenter, randomized, double-blind, double-dummy trial. Eligible outpatients > or =18 years of age with clinical and radiographic evidence of ABS underwent maxillary sinus aspiration before randomization. Primary endpoint was clinical efficacy at the test-of-cure visit (day 17-24). RESULTS: Clinical success rates were 94.5% (242/256) in azithromycin-microspheres-treated patients and 92.8% (233/251) in the levofloxacin group. In patients with documented Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis, clinical cure rates were 97.3% (36/37), 96.3% (26/27), and 100% (8/8), respectively, for the azithromycin group and 92.3% (36/39), 100% (30/30), and 90.9% (10/11), respectively, for the levofloxacin group. CONCLUSIONS: Single-dose azithromycin microspheres provided clinical and bacteriologic efficacy and safety comparable to 10 days of levofloxacin. SIGNIFICANCE: A novel microsphere formulation of azithromycin given as a single dose was safe and effective for the treatment of ABS.
Authors: Martin Desrosiers; Gerald A Evans; Paul K Keith; Erin D Wright; Alan Kaplan; Jacques Bouchard; Anthony Ciavarella; Patrick W Doyle; Amin R Javer; Eric S Leith; Atreyi Mukherji; R Robert Schellenberg; Peter Small; Ian J Witterick Journal: Allergy Asthma Clin Immunol Date: 2011-02-10 Impact factor: 3.406
Authors: Stephanie S Smith; Elisabeth H Ference; Charlesnika T Evans; Bruce K Tan; Robert C Kern; Rakesh K Chandra Journal: Laryngoscope Date: 2014-09-17 Impact factor: 3.325