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

Completed · Phase 3 · Has a placebo group

Conditions studied: Maxillary Sinusitis

In brief

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.

Key facts

Study ID

NCT00643409

Run by

Pfizer

People needed

541

Starts

2003-01-01

Expected to finish

2004-02-01

Last updated by the study team

2011-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients were included if they had a clinical diagnosis of acute bacterial maxillary sinusitis as demonstrated by presence of the cardinal signs and symptoms for a minimum duration of 7 days, a sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis, and 2 or more of following: fever, leukocytosis, frequent coughing, headache, nasal congestion, or post-nasal drainage.

You may not qualify if…

• Patients were excluded if they were treated with any systemic antibiotic within 7 days prior to enrollment, had symptoms lasting for longer than 28 days, had 4 or more episodes of acute sinusitis within the preceding 12 months, had nasal or sinus surgery within 3 months prior (except for a diagnostic procedure), or complicated or nosocomial sinusitis.

Where it is running

• 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
• Pfizer Investigational Site — Jonesboro, Arkansas, United States
• Pfizer Investigational Site — Clovis, California, United States
• Pfizer Investigational Site — Fresno, California, United States
• Pfizer Investigational Site — Fresno, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Bridgeport, Connecticut, United States
• Pfizer Investigational Site — Wichita, Kansas, United States
• Pfizer Investigational Site — Louisville, Kentucky, United States
• Pfizer Investigational Site — New Orleans, Louisiana, United States
• Pfizer Investigational Site — Kalamazoo, Michigan, United States
• Pfizer Investigational Site — Portage, Michigan, United States
• Pfizer Investigational Site — Richland, Michigan, United States
• Pfizer Investigational Site — Three Rivers, Michigan, United States
• Pfizer Investigational Site — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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