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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)

Interventions

  • 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

  • Experimental: 1
  • Experimental: 2

Clinical Trial Outcome Measures

Primary Measures

  • sponsor assessment of clinical response for the Clinical per Protocol population
    • Time Frame: Test of Cure (TOC) visit (Day 17-24)

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Director, Clinical Trial Disclosure Group, Pfizer, Inc.
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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