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:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00643409
First received: March 19, 2008
Last updated: May 10, 2011
Last verified: May 2011
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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:
MedlinePlus related topics:
Sinusitis
Drug Information available for:
Ofloxacin
Azithromycin
Levofloxacin
Azithromycin dihydrate
Ofloxacin hydrochloride
Azithromycin monohydrate
U.S. FDA Resources
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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| 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 May 19, 2013