Status:
COMPLETED
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults
Lead Sponsor:
Pfizer
Conditions:
Maxillary Sinusitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
541 Patients enrolled
Trial Details
Trial ID
NCT00643409
Start Date
January 1 2003
End Date
February 1 2004
Last Update
May 11 2011
Active Locations (89)
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1
Pfizer Investigational Site
Alabaster, Alabama, United States, 35007
2
Pfizer Investigational Site
Birmingham, Alabama, United States, 35205
3
Pfizer Investigational Site
Birmingham, Alabama, United States, 35211
4
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233