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

Condition(s) targeted: Maxillary Sinusitis

Intervention: azithromycin SR (Zithromax; compound: CP-62,993) (Drug); placebo (Other); levofloxacin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: sponsor assessment of clinical response for the Clinical per Protocol population

Secondary outcome:

sponsor assessment of clinical response by baseline pathogen for the Bacteriological per Protocol population

investigator assessment of clinical response for the Clinical per Protocol population

bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population

summary of baseline susceptibilities

adverse events

laboratory abnormalities

sponsor assessment of clinical response for the Clinical per Protocol population

sponsor assessment of clinical response for the remaining study populations

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 sinusitus, 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.

Pfizer Investigational Site, Buenos Aires 1427, Argentina

Pfizer Investigational Site, Santiago, Chile

Pfizer Investigational Site, San Jose, Costa Rica

Pfizer Investigational Site, Prague 5 150 06, Czech Republic

Pfizer Investigational Site, Prague 10 100 34, Czech Republic

Pfizer Investigational Site, Prague 2 128 08, Czech Republic

Pfizer Investigational Site, Tartu 51003, Estonia

Pfizer Investigational Site, Tallinn 13419, Estonia

Pfizer Investigational Site, Rostock 18055, Germany

Pfizer Investigational Site, Vilnius LT-2600, Lithuania

Pfizer Investigational Site, Vilnius LT-2005, Lithuania

Pfizer Investigational Site, Chihuahua 31020, Mexico

Pfizer Investigational Site, Katowice 40-027, Poland

Pfizer Investigational Site, Bielsko-Biala, Poland

Pfizer Investigational Site, Lublin 20-718, Poland

Pfizer Investigational Site, Poznan 60-355, Poland

Pfizer Investigational Site, Moscow 125206, Russian Federation

Pfizer Investigational Site, Moscow 117049, Russian Federation

Pfizer Investigational Site, Smolensk 214019, Russian Federation

Pfizer Investigational Site, Kosice 040 11, Slovakia

Pfizer Investigational Site, Martin 036 01, Slovakia

Pfizer Investigational Site, Bratislava, Slovakia

Pfizer Investigational Site, Montgomery, Alabama 36106, United States

Pfizer Investigational Site, Montgomery, Alabama 36109, United States

Pfizer Investigational Site, Alabaster, Alabama 35007, United States

Pfizer Investigational Site, Pelham, Alabama 35124, United States

Pfizer Investigational Site, Tuscaloosa, Alabama 35404, United States

Pfizer Investigational Site, Tuscaloosa, Alabama 35406, United States

Pfizer Investigational Site, BIRMINGHAM, Alabama 35233, United States

Pfizer Investigational Site, Birmingham, Alabama 35205, United States

Pfizer Investigational Site, Birmingham, Alabama 35211, United States

Pfizer Investigational Site, Hueytown, Alabama 35023, United States

Pfizer Investigational Site, Jonesboro, Arkansas 72401, United States

Pfizer Investigational Site, Clovis, California 93611, United States

Pfizer Investigational Site, FRESNO, California 93710, United States

Pfizer Investigational Site, Fresno, California 93720, United States

Pfizer Investigational Site, FRESNO, California 93720, United States

Pfizer Investigational Site, Fresno, California 93710, United States

Pfizer Investigational Site, San Diego, California 92103, United States

Pfizer Investigational Site, San Diego, California 92117, United States

Pfizer Investigational Site, San Diego, California 92123, United States

Pfizer Investigational Site, Bridgeport, Connecticut 06606, United States

Pfizer Investigational Site, Unknown, Heredia, Costa Rica

Pfizer Investigational Site, Wichita, Kansas 67208, United States

Pfizer Investigational Site, Bangalore, Karnataka 560 034, India

Pfizer Investigational Site, Louisville, Kentucky 40207, United States

Pfizer Investigational Site, Kochi, Kerala 682 026, India

Pfizer Investigational Site, New Orleans, Louisiana 70115, United States

Pfizer Investigational Site, Kalamazoo, Michigan 49008, United States

Pfizer Investigational Site, Portage, Michigan 49024, United States

Pfizer Investigational Site, Richland, Michigan 49083, United States

Pfizer Investigational Site, Three Rivers, Michigan 49093, United States

Pfizer Investigational Site, Jefferson City, Missouri 65101, United States

Pfizer Investigational Site, MISSOULA, Montana 59804, United States

Pfizer Investigational Site, Missoula, Montana 59801, United States

Pfizer Investigational Site, CHARLOTTE, North Carolina 28210, United States

Pfizer Investigational Site, Charlote, North Carolina 28210, United States

Pfizer Investigational Site, Cincinnati, Ohio 45241, United States

Pfizer Investigational Site, Cincinnati, Ohio 45242, United States

Pfizer Investigational Site, DAYTON, Ohio 45406, United States

Pfizer Investigational Site, Dayton, Ohio 45402, United States

Pfizer Investigational Site, Eugene, Oregon 97401, United States

Pfizer Investigational Site, Eugene, Oregon 97404, United States

Pfizer Investigational Site, Medford, Oregon 97504, United States

Pfizer Investigational Site, Unknown, Parsti vald/Viljandimaa 71024, Estonia

Pfizer Investigational Site, MORRISVILLE, Pennsylvania 19067, United States

Pfizer Investigational Site, Norristown, Pennsylvania 19401, United States

Pfizer Investigational Site, Plymouth Meeting, Pennsylvania 19462, United States

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, ORANGEBURG, South Carolina 29118, United States

Pfizer Investigational Site, Nashville, Tennessee 37203, United States

Pfizer Investigational Site, El Paso, Texas 79902, United States

Pfizer Investigational Site, WICHITA FALLS, Texas 76309, United States

Pfizer Investigational Site, Wichita Falls, Texas 76302, United States

Pfizer Investigational Site, Bryan, Texas 77802, United States

Pfizer Investigational Site, San Antonio, Texas 78205, United States

Pfizer Investigational Site, San Antonio, Texas 78224, United States

Pfizer Investigational Site, San Antonio, Texas 78229, United States

Pfizer Investigational Site, Amarillo, Texas 79109, United States

Pfizer Investigational Site, Amarillo, Texas 79119, United States

Pfizer Investigational Site, Amarillo, Texas 79124, United States

Pfizer Investigational Site, Houston, Texas 77015, United States

Pfizer Investigational Site, Houston, Texas 77074, United States

Pfizer Investigational Site, Pasadena, Texas 77505, United States

Pfizer Investigational Site, Murray, Utah 84107, United States

Pfizer Investigational Site, Salt Lake City, Utah 84102, United States

Pfizer Investigational Site, Salt Lake City, Utah 84121, United States

Pfizer Investigational Site, SALT LAKE CITY, Utah 84102, United States

Pfizer Investigational Site, Salt Lake City, Utah 84109, United States

Pfizer Investigational Site, Lucknow, Uttar Pradesh 226020, India

To obtain contact information for a study center near you, click here.

Starting date: January 2003
Ending date: February 2004
Last updated: March 19, 2008