Tags

Type your tag names separated by a space and hit enter

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.
Otolaryngol Head Neck Surg. 2005 Aug; 133(2):194-200.OH

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 > 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+Show Affiliations

Vanderbilt Medical School, Nashville, Tennessee, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16087013

Citation

Murray, John J., et al. "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." Otolaryngology--head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery, vol. 133, no. 2, 2005, pp. 194-200.
Murray JJ, Emparanza P, Lesinskas E, et al. 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. Otolaryngol Head Neck Surg. 2005;133(2):194-200.
Murray, J. J., Emparanza, P., Lesinskas, E., Tawadrous, M., & Breen, J. D. (2005). 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. Otolaryngology--head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery, 133(2), 194-200.
Murray JJ, et al. 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. Otolaryngol Head Neck Surg. 2005;133(2):194-200. PubMed PMID: 16087013.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Murray,John J, AU - Emparanza,Paz, AU - Lesinskas,Eugenijus, AU - Tawadrous,Margaret, AU - Breen,Jeanne D, PY - 2004/12/23/received PY - 2005/04/22/accepted PY - 2005/8/10/pubmed PY - 2005/9/8/medline PY - 2005/8/10/entrez SP - 194 EP - 200 JF - Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery JO - Otolaryngol Head Neck Surg VL - 133 IS - 2 N2 - 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. SN - 0194-5998 UR - https://www.unboundmedicine.com/medline/citation/16087013/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_ DB - PRIME DP - Unbound Medicine ER -