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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00643409
First received: March 19, 2008
Last updated: May 10, 2011
Last verified: May 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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) ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00643409

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Locations
United States, Alabama
Pfizer Investigational Site
Alabaster, Alabama, United States, 35007
Pfizer Investigational Site
Birmingham, Alabama, United States, 35211
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
Pfizer Investigational Site
Birmingham, Alabama, United States, 35205
Pfizer Investigational Site
Hueytown, Alabama, United States, 35023
Pfizer Investigational Site
Montgomery, Alabama, United States, 36109
Pfizer Investigational Site
Montgomery, Alabama, United States, 36106
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, 59804
Pfizer Investigational Site
Missoula, Montana, United States, 59801
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, 45406
Pfizer Investigational Site
Dayton, Ohio, United States, 45402
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, 79124
Pfizer Investigational Site
Amarillo, Texas, United States, 79119
Pfizer Investigational Site
Amarillo, Texas, United States, 79109
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, 78224
Pfizer Investigational Site
San Antonio, Texas, United States, 78205
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, 84121
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84109
Argentina
Pfizer Investigational Site
Buenos Aires, Argentina, 1427
Chile
Pfizer Investigational Site
Santiago, Chile
Costa Rica
Pfizer Investigational Site
Unknown, Heredia, 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
Unknown, Parsti vald/Viljandimaa, Estonia, 71024
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-2600
Pfizer Investigational Site
Vilnius, Lithuania, LT-2005
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, 125206
Pfizer Investigational Site
Moscow, Russian Federation, 117049
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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00643409     History of Changes
Other Study ID Numbers: A0661078
Study First Received: March 19, 2008
Last Updated: May 10, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Maxillary Sinusitis
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Ofloxacin
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on April 15, 2014