Clinical Trial: A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Acute Bacterial Maxillary Sinusitis in
Brief Summary: 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.
Detailed Summary:
Sponsor: Pfizer
Current Primary Outcome: sponsor assessment of clinical response for the Clinical per Protocol population [ Time Frame: Test of Cure (TOC) visit (Day 17-24) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Pfizer
Dates:
Date Received: March 19, 2008
Date Started: January 2003
Date Completion:
Last Updated: May 10, 2011
Last Verified: May 2011