This study was performed to confirm that a single 2.0-g dose of azithromycin SR is at least as effective as 7 days of levofloxacin 500 mg/day in adults with acute exacerbation of chronic bronchitis Secondary objectives: To assess safety and the bacteriologic efficacy of both treatment regimens
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
551
sponsor assessment of clinical response in the Clinical Per Protocol population
Time frame: Test of Cure (TOC) visit (Day 14-21)
investigator assessment of clinical response in 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
sponsor assessment of clinical response in the Clinical Per Protocol population
Time frame: Long-Term Follow-Up (LTFU) visit (Day 28-35)
Summary of baseline susceptibilities
Time frame: Study Endpoint
adverse events
Time frame: Continuous
clinical laboratory tests
Time frame: Baseline and EOT visit
sponsor assessment of clinical response in the Clinical Per Protocol population
Time frame: End of Treatment (EOT) visit (Day 8-11)
sponsor assessment of clinical response in the remaining study populations
Time frame: TOC visit
sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population
Time frame: EOT visit and TOC visit
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500 mg (two 250 mg capsules) by mouth once daily for 7 days
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Columbiana, Alabama, United States
Pfizer Investigational Site
Tallassee, Alabama, United States
Pfizer Investigational Site
Mesa, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Tempe, Arizona, United States
Pfizer Investigational Site
Daytona Beach, Florida, United States
Pfizer Investigational Site
Merritt Island, Florida, United States
Pfizer Investigational Site
Austell, Georgia, United States
...and 65 more locations