A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults

• Drug: azithromycin SR (Zithromax; compound: CP-62,993)
  
  Azithromycin SR 2.0 g by mouth in the form of a slurry x 1 dose
• Other: placebo
  
  placebo
• Drug: levofloxacin
  
  levofloxacin 500 mg capsule by mouth qd x 10 days

• Experimental: 1
  
  Interventions:
  

  • Drug: azithromycin SR (Zithromax; compound: CP-62,993)
  • Other: placebo
• Experimental: 2
  
  Interventions:
  

  • Drug: levofloxacin
  • Other: placebo

Inclusion Criteria:

Patients were included if they had a clinical diagnosis of acute bacterial maxillary sinusitis as demonstrated by presence of the cardinal signs and symptoms for a minimum duration of 7 days, a sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis, and 2 or more of following: fever, leukocytosis, frequent coughing, headache, nasal congestion, or post-nasal drainage.

Exclusion Criteria:

Patients were excluded if they were treated with any systemic antibiotic within 7 days prior to enrollment, had symptoms lasting for longer than 28 days, had 4 or more episodes of acute sinusitis within the preceding 12 months, had nasal or sinus surgery within 3 months prior (except for a diagnostic procedure), or complicated or nosocomial sinusitis.