The study was performed to confirm that a single, 2.0 g oral dose of azithromycin sustained release (SR) at least as effective as 7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily, when used to treat adults with mild to moderate community acquired pneumonia (CAP), and that both treatments were safe.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
504
7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily
Single, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily
sponsor assessment of clinical response (clinical cure rate) in the Clinical Per Protocol population
Time frame: Test of Cure (TOC) visit (Day 14-21)
bacteriologic response (eradication rate) in the Bacteriological Per Protocol population
Time frame: TOC visit
investigator assessment of clinical response in the Clinical Per Protocol population
Time frame: TOC visit
sponsor assessment of clinical response by baseline pathogen
Time frame: End of Treatment (EOT) visit (Day 8-11) and TOC visit
sponsor assessment of clinical response in the non-primary population
Time frame: EOT visit and TOC visit
sponsor assessment of clinical responses in the Clinical Per Protocol population
Time frame: EOT visit and Long-Term Follow-Up (LTFU) visit (Day 28-35)
susceptibilities of baseline pathogens
Time frame: Study endpoint
adverse events
Time frame: Continuous
vital signs
Time frame: Baseline, On-Treatment (OT) visit (Day 3-5), and TOC visit
physical examination
Time frame: Baseline
clinical laboratory assessments (blood chemistry and hematology)
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Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Haleyville, Alabama, United States
Pfizer Investigational Site
Montgomery, Alabama, United States
Pfizer Investigational Site
Montgomery, 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
La Jolla, California, United States
...and 62 more locations
Time frame: Baseline and TOC visit