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.
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).


METHODS
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.


CONCLUSIONS
A novel microsphere formulation of azithromycin given as a single dose was safe and effective for the treatment of ABS.
Murray
John J
JJ
Vanderbilt Medical School, Nashville, Tennessee, USA.
Emparanza
Paz
P
Lesinskas
Eugenijus
E
Tawadrous
Margaret
M
Breen
Jeanne D
JD
D000208:Acute Disease; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017963:Azithromycin / Q000008:administration & dosage*; D001424:Bacterial Infections / Q000188:drug therapy* / Q000382:microbiology*; D002626:Chemistry, Pharmaceutical; D016001:Confidence Intervals; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007391:International Cooperation; D064704:Levofloxacin; D008297:Male; D015523:Maxillary Sinusitis / Q000188:drug therapy* / Q000382:microbiology*; D008863:Microspheres; D008875:Middle Aged; D015242:Ofloxacin / Q000008:administration & dosage*; D011336:Probability; D018570:Risk Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome
D064704:Levofloxacin; D017963:Azithromycin; D015242:Ofloxacin