1. Efficacy and Safety of a Novel, Single‐dose Azithromycin Microsphere Formulation Versus 10 Days of Levofloxacin for the Treatment of Acute Bacterial Sinusitis in Adults
- Author
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Paz Emparanza, Margaret Tawadrous, John J. Murray, Eugenijus Lesinskas, and Jeanne D. Breen
- Subjects
Male ,Ofloxacin ,Chemistry, Pharmaceutical ,International Cooperation ,Administration, Oral ,Levofloxacin ,Azithromycin ,030204 cardiovascular system & hematology ,medicine.disease_cause ,Severity of Illness Index ,Haemophilus influenzae ,Moraxella catarrhalis ,0302 clinical medicine ,Clinical endpoint ,Sinusitis ,Aged, 80 and over ,Cross-Over Studies ,biology ,Bacterial Infections ,Middle Aged ,Maxillary Sinusitis ,Microspheres ,Treatment Outcome ,030220 oncology & carcinogenesis ,Acute Disease ,Female ,medicine.drug ,Adult ,medicine.medical_specialty ,Randomization ,Adolescent ,Risk Assessment ,Drug Administration Schedule ,03 medical and health sciences ,Double-Blind Method ,Internal medicine ,Streptococcus pneumoniae ,Confidence Intervals ,medicine ,Humans ,Aged ,Probability ,Dose-Response Relationship, Drug ,business.industry ,medicine.disease ,biology.organism_classification ,Surgery ,Otorhinolaryngology ,business ,Follow-Up Studies - Abstract
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 ≥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.
- Published
- 2005
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