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

May 10, 2011 updated by: Pfizer

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

541

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

        • Pfizer Investigational Site
  • Argentina
      • Buenos Aires, Argentina, 1427
        • Pfizer Investigational Site
  • Chile
      • Santiago, Chile
        • Pfizer Investigational Site
  • Costa Rica
      • San Jose, Costa Rica
        • Pfizer Investigational Site
    • San Jose
      • Bo. Aranjuez, San Jose, Costa Rica
        • Pfizer Investigational Site
      • Escazu, San Jose, Costa Rica
        • Pfizer Investigational Site
      • Guadalupe, San Jose, Costa Rica
        • Pfizer Investigational Site
      • La Uruca, San Jose, Costa Rica
        • Pfizer Investigational Site
  • Czech Republic
      • Prague 10, Czech Republic, 100 34
        • Pfizer Investigational Site
      • Prague 2, Czech Republic, 128 08
        • Pfizer Investigational Site
      • Prague 5, Czech Republic, 150 06
        • Pfizer Investigational Site
  • Estonia
      • Tallinn, Estonia, 13419
        • Pfizer Investigational Site
      • Tartu, Estonia, 51003
        • Pfizer Investigational Site
  • Germany
      • Rostock, Germany, 18055
        • Pfizer Investigational Site
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560 034
        • Pfizer Investigational Site
    • Kerala
      • Kochi, Kerala, India, 682 026
        • Pfizer Investigational Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226020
        • Pfizer Investigational Site
  • Lithuania
      • Vilnius, Lithuania, LT-2005
        • Pfizer Investigational Site
      • Vilnius, Lithuania, LT-2600
        • Pfizer Investigational Site
  • Mexico
      • Chihuahua, Mexico, 31020
        • Pfizer Investigational Site
  • Poland
      • Bielsko-Biala, Poland
        • Pfizer Investigational Site
      • Katowice, Poland, 40-027
        • Pfizer Investigational Site
      • Lublin, Poland, 20-718
        • Pfizer Investigational Site
      • Poznan, Poland, 60-355
        • Pfizer Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 117049
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 125206
        • Pfizer Investigational Site
      • Smolensk, Russian Federation, 214019
        • Pfizer Investigational Site
  • Slovakia
      • Bratislava, Slovakia
        • Pfizer Investigational Site
      • Kosice, Slovakia, 040 11
        • Pfizer Investigational Site
      • Martin, Slovakia, 036 01
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Alabaster, Alabama, United States, 35007
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35205
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35233
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35211
        • Pfizer Investigational Site
      • Hueytown, Alabama, United States, 35023
        • Pfizer Investigational Site
      • Montgomery, Alabama, United States, 36106
        • Pfizer Investigational Site
      • Montgomery, Alabama, United States, 36109
        • Pfizer Investigational Site
      • Pelham, Alabama, United States, 35124
        • Pfizer Investigational Site
      • Tuscaloosa, Alabama, United States, 35404
        • Pfizer Investigational Site
      • Tuscaloosa, Alabama, United States, 35406
        • Pfizer Investigational Site
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Pfizer Investigational Site
    • California
      • Clovis, California, United States, 93611
        • Pfizer Investigational Site
      • Fresno, California, United States, 93720
        • Pfizer Investigational Site
      • Fresno, California, United States, 93710
        • Pfizer Investigational Site
      • San Diego, California, United States, 92103
        • Pfizer Investigational Site
      • San Diego, California, United States, 92123
        • Pfizer Investigational Site
      • San Diego, California, United States, 92117
        • Pfizer Investigational Site
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Pfizer Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67208
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Pfizer Investigational Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49008
        • Pfizer Investigational Site
      • Portage, Michigan, United States, 49024
        • Pfizer Investigational Site
      • Richland, Michigan, United States, 49083
        • Pfizer Investigational Site
      • Three Rivers, Michigan, United States, 49093
        • Pfizer Investigational Site
    • Missouri
      • Jefferson City, Missouri, United States, 65101
        • Pfizer Investigational Site
    • Montana
      • Missoula, Montana, United States, 59801
        • Pfizer Investigational Site
      • Missoula, Montana, United States, 59804
        • Pfizer Investigational Site
    • North Carolina
      • Charlote, North Carolina, United States, 28210
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28210
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45241
        • Pfizer Investigational Site
      • Dayton, Ohio, United States, 45402
        • Pfizer Investigational Site
      • Dayton, Ohio, United States, 45406
        • Pfizer Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pfizer Investigational Site
      • Eugene, Oregon, United States, 97404
        • Pfizer Investigational Site
      • Medford, Oregon, United States, 97504
        • Pfizer Investigational Site
    • Pennsylvania
      • Morrisville, Pennsylvania, United States, 19067
        • Pfizer Investigational Site
      • Norristown, Pennsylvania, United States, 19401
        • Pfizer Investigational Site
      • Plymouth Meeting, Pennsylvania, United States, 19462
        • Pfizer Investigational Site
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site
    • Texas
      • Amarillo, Texas, United States, 79109
        • Pfizer Investigational Site
      • Amarillo, Texas, United States, 79119
        • Pfizer Investigational Site
      • Amarillo, Texas, United States, 79124
        • Pfizer Investigational Site
      • Bryan, Texas, United States, 77802
        • Pfizer Investigational Site
      • El Paso, Texas, United States, 79902
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77015
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77074
        • Pfizer Investigational Site
      • Pasadena, Texas, United States, 77505
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78205
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78224
        • Pfizer Investigational Site
      • Wichita Falls, Texas, United States, 76309
        • Pfizer Investigational Site
      • Wichita Falls, Texas, United States, 76302
        • Pfizer Investigational Site
    • Utah
      • Murray, Utah, United States, 84107
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84102
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84109
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84121
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Other: placebo
placebo
Drug: azithromycin SR (Zithromax; compound: CP-62,993)
Azithromycin SR 2.0 g by mouth in the form of a slurry x 1 dose
Experimental: 2
Other: placebo
placebo
Drug: levofloxacin
levofloxacin 500 mg capsule by mouth qd x 10 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: Continuous
Continuous
sponsor assessment of clinical response by baseline pathogen for the Bacteriological per Protocol population
Time Frame: EOT visit and TOC visit
EOT visit and TOC visit
investigator assessment of clinical response for the Clinical per Protocol population
Time Frame: TOC visit
TOC visit
bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population
Time Frame: TOC visit
TOC visit
summary of baseline susceptibilities
Time Frame: Study endpoint
Study endpoint
laboratory abnormalities
Time Frame: during and post-treatment
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)
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
EOT visit and TOC visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

May 11, 2011

Last Update Submitted That Met QC Criteria

May 10, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0661078

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe