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

• ClinicalTrials.gov Identifier: NCT00643409
• Recruitment Status: Completed
• First Posted: March 26, 2008
• Last Update Posted: May 11, 2011
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: March 19, 2008
• First Posted Date: March 26, 2008
• Last Update Posted Date: May 11, 2011
• Study Start Date: January 2003
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: March 19, 2008): sponsor assessment of clinical response for the Clinical per Protocol population [ Time Frame: Test of Cure (TOC) visit (Day 17-24) ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 19, 2008)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults
• 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
• 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 treat adults with uncomplicated, acute bacterial sinus infections, and to evaluate the safety of both treatments.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Maxillary Sinusitis

Intervention

• 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

Study Arms

• Experimental: 1
  Interventions:

  • Drug: azithromycin SR (Zithromax; compound: CP-62,993)
  • Other: placebo
• Experimental: 2
  Interventions:

  • Drug: levofloxacin
  • Other: placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 10, 2011): 541
• Original Actual Enrollment (submitted: March 19, 2008): 504
• Actual Study Completion Date: February 2004
• Primary Completion Date: Not Provided

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Chile, Costa Rica, Czech Republic, Estonia, Germany, India, Lithuania, Mexico, Poland, Russian Federation, Slovakia, United States

Administrative Information

• NCT Number: NCT00643409
• Other Study ID Numbers: A0661078
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: May 2011