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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00643409
First Posted: March 26, 2008
Last Update Posted: May 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
March 19, 2008
March 26, 2008
May 11, 2011
January 2003
Not Provided
sponsor assessment of clinical response for the Clinical per Protocol population [ Time Frame: Test of Cure (TOC) visit (Day 17-24) ]
Same as current
Complete list of historical versions of study NCT00643409 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Maxillary Sinusitis
  • 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
  • Experimental: 1
    Interventions:
    • Drug: azithromycin SR (Zithromax; compound: CP-62,993)
    • Other: placebo
  • Experimental: 2
    Interventions:
    • Drug: levofloxacin
    • Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
541
February 2004
Not Provided

Inclusion Criteria:

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 Criteria:

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Chile,   Costa Rica,   Czech Republic,   Estonia,   Germany,   India,   Lithuania,   Mexico,   Poland,   Russian Federation,   Slovakia,   United States
 
 
NCT00643409
A0661078
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP