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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| azithromycin SR (Zithromax; compound: CP-62,993) | Drug | Azithromycin SR 2.0 g by mouth in the form of a slurry x 1 dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| sponsor assessment of clinical response for the Clinical per Protocol population | Test of Cure (TOC) visit (Day 17-24) |
| Measure | Description | Time Frame |
|---|---|---|
| sponsor assessment of clinical response by baseline pathogen for the Bacteriological per Protocol population | EOT visit and TOC visit | |
| investigator assessment of clinical response for the Clinical per Protocol population | TOC visit |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Alabaster | Alabama | 35007 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| placebo | Other | placebo |
|
| levofloxacin | Drug | levofloxacin 500 mg capsule by mouth qd x 10 days |
|
| placebo | Other | placebo |
|
| bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population | TOC visit |
| summary of baseline susceptibilities | Study endpoint |
| adverse events | Continuous |
| laboratory abnormalities | during and post-treatment |
| sponsor assessment of clinical response for the Clinical per Protocol population | End of Treatment (EOT) visit (Day 11-13) |
| sponsor assessment of clinical response for the remaining study populations | EOT visit and TOC visit |
| Birmingham |
| Alabama |
| 35205 |
| United States |
| Pfizer Investigational Site | Birmingham | Alabama | 35211 | United States |
| Pfizer Investigational Site | Birmingham | Alabama | 35233 | United States |
| Pfizer Investigational Site | Hueytown | Alabama | 35023 | United States |
| Pfizer Investigational Site | Montgomery | Alabama | 36106 | United States |
| Pfizer Investigational Site | Montgomery | Alabama | 36109 | 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 | 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 | 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 | Wichita | Kansas | 67208 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40207 | United States |
| 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 | 59801 | United States |
| Pfizer Investigational Site | Missoula | Montana | 59804 | United States |
| Pfizer Investigational Site | Charlote | North Carolina | 28210 | United States |
| Pfizer Investigational Site | Charlotte | 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 | 45402 | United States |
| Pfizer Investigational Site | Dayton | Ohio | 45406 | 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 | 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 | Orangeburg | South Carolina | 29118 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37203 | 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 | Bryan | Texas | 77802 | United States |
| Pfizer Investigational Site | El Paso | Texas | 79902 | 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 | 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 | Wichita Falls | Texas | 76302 | United States |
| Pfizer Investigational Site | Wichita Falls | Texas | 76309 | 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 | 84109 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84121 | United States |
| Pfizer Investigational Site | Buenos Aires | 1427 | Argentina |
| Pfizer Investigational Site | Santiago | Chile |
| Pfizer Investigational Site | Bo. Aranjuez | Provincia de San José | Costa Rica |
| Pfizer Investigational Site | Escazú | Provincia de San José | Costa Rica |
| Pfizer Investigational Site | Guadalupe | Provincia de San José | Costa Rica |
| Pfizer Investigational Site | San José | Provincia de San José | Costa Rica |
| Pfizer Investigational Site | Uruca | Provincia de San José | Costa Rica |
| Pfizer Investigational Site | Prague | 100 34 | Czechia |
| Pfizer Investigational Site | Prague | 128 08 | Czechia |
| Pfizer Investigational Site | Prague | 150 06 | Czechia |
| Pfizer Investigational Site | Tallinn | 13419 | Estonia |
| Pfizer Investigational Site | Tartu | 51003 | Estonia |
| Pfizer Investigational Site | Rostock | 18055 | Germany |
| Pfizer Investigational Site | Bangalore | Karnataka | 560 034 | India |
| Pfizer Investigational Site | Kochi | Kerala | 682 026 | India |
| Pfizer Investigational Site | Lucknow | Uttar Pradesh | 226020 | India |
| Pfizer Investigational Site | Vilnius | LT-2005 | Lithuania |
| Pfizer Investigational Site | Vilnius | LT-2600 | Lithuania |
| Pfizer Investigational Site | Chihuahua City | Chihuahua | 31020 | Mexico |
| Pfizer Investigational Site | Bielsko-Biala | Poland |
| Pfizer Investigational Site | Katowice | 40-027 | Poland |
| Pfizer Investigational Site | Lublin | 20-718 | Poland |
| Pfizer Investigational Site | Poznan | 60-355 | Poland |
| Pfizer Investigational Site | Moscow | 117049 | Russia |
| Pfizer Investigational Site | Moscow | 125206 | Russia |
| Pfizer Investigational Site | Smolensk | 214019 | Russia |
| Pfizer Investigational Site | Bratislava | Slovakia | Slovakia |
| Pfizer Investigational Site | Košice | Slovakia | 040 11 | Slovakia |
| Pfizer Investigational Site | Martin | Slovakia | 036 01 | Slovakia |
| Pfizer Investigational Site |
| ID | Term |
|---|---|
| D015523 | Maxillary Sinusitis |
| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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