Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2

Primary Measures

• sponsor assessment of clinical response for the Clinical per Protocol population
  • Time Frame: Test of Cure (TOC) visit (Day 17-24)
    Safety Issue?: No

Secondary Measures

• sponsor assessment of clinical response by baseline pathogen for the Bacteriological per Protocol population
  • Time Frame: EOT visit and TOC visit
    Safety Issue?: No
• investigator assessment of clinical response for the Clinical per Protocol population
  • Time Frame: TOC visit
    Safety Issue?: No
• bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population
  • Time Frame: TOC visit
    Safety Issue?: No
• summary of baseline susceptibilities
  • Time Frame: Study endpoint
    Safety Issue?: No
• adverse events
  • Time Frame: Continuous
    Safety Issue?: Yes
• laboratory abnormalities
  • Time Frame: during and post-treatment
    Safety Issue?: Yes
• sponsor assessment of clinical response for the Clinical per Protocol population
  • Time Frame: End of Treatment (EOT) visit (Day 11-13)
    Safety Issue?: No
• sponsor assessment of clinical response for the remaining study populations
  • Time Frame: EOT visit and TOC visit
    Safety Issue?: No

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 sinusitus, 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00643409

Study ID Number: A0661078

ClinicalTrials.gov Identifier: NCT00643409

Health Authority: United States: Food and Drug Administration

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