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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:
ClinicalTrials.gov Identifier:
NCT00643409
First Posted: March 26, 2008
Last Update Posted: May 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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.

Condition Intervention Phase
Maxillary Sinusitis Drug: azithromycin SR (Zithromax; compound: CP-62,993) Other: placebo Drug: levofloxacin Phase 3

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Secondary Outcome 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 ]

Enrollment: 541
Study Start Date: January 2003
Study Completion Date: February 2004
Arms Assigned Interventions
Experimental: 1 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
Experimental: 2 Drug: levofloxacin
levofloxacin 500 mg capsule by mouth qd x 10 days
Other: placebo
placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643409


  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Alabaster, Alabama, United States, 35007
Pfizer Investigational Site
Birmingham, Alabama, United States, 35205
Pfizer Investigational Site
Birmingham, Alabama, United States, 35211
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
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
United States, Arkansas
Pfizer Investigational Site
Jonesboro, Arkansas, United States, 72401
United States, California
Pfizer Investigational Site
Clovis, California, United States, 93611
Pfizer Investigational Site
Fresno, California, United States, 93710
Pfizer Investigational Site
Fresno, California, United States, 93720
Pfizer Investigational Site
San Diego, California, United States, 92103
Pfizer Investigational Site
San Diego, California, United States, 92117
Pfizer Investigational Site
San Diego, California, United States, 92123
United States, Connecticut
Pfizer Investigational Site
Bridgeport, Connecticut, United States, 06606
United States, Kansas
Pfizer Investigational Site
Wichita, Kansas, United States, 67208
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40207
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70115
United States, Michigan
Pfizer Investigational Site
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
United States, Missouri
Pfizer Investigational Site
Jefferson City, Missouri, United States, 65101
United States, Montana
Pfizer Investigational Site
Missoula, Montana, United States, 59801
Pfizer Investigational Site
Missoula, Montana, United States, 59804
United States, North Carolina
Pfizer Investigational Site
Charlote, North Carolina, United States, 28210
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28210
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45241
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45242
Pfizer Investigational Site
Dayton, Ohio, United States, 45402
Pfizer Investigational Site
Dayton, Ohio, United States, 45406
United States, Oregon
Pfizer Investigational Site
Eugene, Oregon, United States, 97401
Pfizer Investigational Site
Eugene, Oregon, United States, 97404
Pfizer Investigational Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
Pfizer Investigational Site
Morrisville, Pennsylvania, United States, 19067
Pfizer Investigational Site
Norristown, Pennsylvania, United States, 19401
Pfizer Investigational Site
Plymouth Meeting, Pennsylvania, United States, 19462
United States, South Carolina
Pfizer Investigational Site
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Pfizer Investigational Site
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, 78205
Pfizer Investigational Site
San Antonio, Texas, United States, 78224
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Pfizer Investigational Site
Wichita Falls, Texas, United States, 76302
Pfizer Investigational Site
Wichita Falls, Texas, United States, 76309
United States, Utah
Pfizer Investigational Site
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
Argentina
Pfizer Investigational Site
Buenos Aires, Argentina, 1427
Chile
Pfizer Investigational Site
Santiago, Chile
Costa Rica
Pfizer Investigational Site
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
San Jose, Costa Rica
Czech Republic
Pfizer Investigational Site
Prague 10, Czech Republic, 100 34
Pfizer Investigational Site
Prague 2, Czech Republic, 128 08
Pfizer Investigational Site
Prague 5, Czech Republic, 150 06
Estonia
Pfizer Investigational Site
Tallinn, Estonia, 13419
Pfizer Investigational Site
Tartu, Estonia, 51003
Germany
Pfizer Investigational Site
Rostock, Germany, 18055
India
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 034
Pfizer Investigational Site
Kochi, Kerala, India, 682 026
Pfizer Investigational Site
Lucknow, Uttar Pradesh, India, 226020
Lithuania
Pfizer Investigational Site
Vilnius, Lithuania, LT-2005
Pfizer Investigational Site
Vilnius, Lithuania, LT-2600
Mexico
Pfizer Investigational Site
Chihuahua, Mexico, 31020
Poland
Pfizer Investigational Site
Bielsko-Biala, Poland
Pfizer Investigational Site
Katowice, Poland, 40-027
Pfizer Investigational Site
Lublin, Poland, 20-718
Pfizer Investigational Site
Poznan, Poland, 60-355
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 117049
Pfizer Investigational Site
Moscow, Russian Federation, 125206
Pfizer Investigational Site
Smolensk, Russian Federation, 214019
Slovakia
Pfizer Investigational Site
Bratislava, Slovakia
Pfizer Investigational Site
Kosice, Slovakia, 040 11
Pfizer Investigational Site
Martin, Slovakia, 036 01
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00643409     History of Changes
Other Study ID Numbers: A0661078
First Submitted: March 19, 2008
First Posted: March 26, 2008
Last Update Posted: May 11, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Sinusitis
Maxillary Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Levofloxacin
Ofloxacin
Azithromycin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors