NCT00643409

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

A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Acute Bacterial Maxillary Sinusitis in Adults Undergoing Diagnostic Sinus Aspiration

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 541 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Maxillary Sinusitis

Interventions

Type	Name	Description
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
OTHER	placebo	placebo

Timeline

• Start date: 2003-01-01
• Completion: 2004-02-01
• First posted: 2008-03-26
• Last updated: 2011-05-11

Locations

89 sites across 13 countries: United States, Argentina, Chile, Costa Rica, Czechia, Estonia, Germany, India, Lithuania, Mexico, Poland, Russia, Slovakia