The objectives of the study were to confirm that a single, 2.0-g dose of azithromycin sustained release (SR) was at least as effective to 10 days of oral levofloxacin 500 mg once a day, when used to treat adults with uncomplicated, acute bacterial sinus infections, and to evaluate the safety of both treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
541
Azithromycin SR 2.0 g by mouth in the form of a slurry x 1 dose
placebo
levofloxacin 500 mg capsule by mouth qd x 10 days
sponsor assessment of clinical response for the Clinical per Protocol population
Time frame: Test of Cure (TOC) visit (Day 17-24)
sponsor assessment of clinical response by baseline pathogen for the Bacteriological per Protocol population
Time frame: EOT visit and TOC visit
investigator assessment of clinical response for the Clinical per Protocol population
Time frame: TOC visit
bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population
Time frame: TOC visit
summary of baseline susceptibilities
Time frame: Study endpoint
adverse events
Time frame: Continuous
laboratory abnormalities
Time frame: during and post-treatment
sponsor assessment of clinical response for the Clinical per Protocol population
Time frame: End of Treatment (EOT) visit (Day 11-13)
sponsor assessment of clinical response for the remaining study populations
Time frame: EOT visit and TOC visit
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placebo
Pfizer Investigational Site
Alabaster, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Hueytown, Alabama, United States
Pfizer Investigational Site
Montgomery, Alabama, United States
Pfizer Investigational Site
Montgomery, Alabama, United States
Pfizer Investigational Site
Pelham, Alabama, United States
Pfizer Investigational Site
Tuscaloosa, Alabama, United States
Pfizer Investigational Site
Tuscaloosa, Alabama, United States
...and 79 more locations