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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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00643409
First received: March 19, 2008
Last updated: May 10, 2011
Last verified: May 2011

March 19, 2008
May 10, 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) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • investigator assessment of clinical response for the Clinical per Protocol population [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
  • bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
  • summary of baseline susceptibilities [ Time Frame: Study endpoint ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]
  • laboratory abnormalities [ Time Frame: during and post-treatment ] [ Designated as safety issue: Yes ]
  • sponsor assessment of clinical response for the Clinical per Protocol population [ Time Frame: End of Treatment (EOT) visit (Day 11-13) ] [ Designated as safety issue: No ]
  • sponsor assessment of clinical response for the remaining study populations [ Time Frame: EOT visit and TOC visit ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Chile,   Costa Rica,   Czech Republic,   Estonia,   Germany,   India,   Lithuania,   Mexico,   Poland,   Russian Federation,   Slovakia
 
NCT00643409
A0661078
No
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