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

NCT00643409 | Completed Phase 3

• 1 other identifier: A0661078
• Study Type: interventional
• Target: 541
• Locations: 13 countries
• Sites: 88

Brief Summary

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.

Conditions

Maxillary Sinusitis

Outcome Measures

Primary Outcomes (1)

• sponsor assessment of clinical response for the Clinical per Protocol population

  Test of Cure (TOC) visit (Day 17-24)

Secondary Outcomes (8)

• 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

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

  TOC visit

• summary of baseline susceptibilities

  Study endpoint

• adverse events

  Continuous

Study Arms (2)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

Drug: levofloxacin; Other: placebo

Interventions

azithromycin SR (Zithromax; compound: CP-62,993) DRUG

Azithromycin SR 2.0 g by mouth in the form of a slurry x 1 dose

1

placebo OTHER

placebo

1

levofloxacin DRUG

levofloxacin 500 mg capsule by mouth qd x 10 days

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (89)

Pfizer Investigational Site

Alabaster, Alabama, 35007, United States

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Birmingham, Alabama, 35205, United States

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Birmingham, Alabama, 35211, United States

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Birmingham, Alabama, 35233, United States

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Hueytown, Alabama, 35023, United States

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Montgomery, Alabama, 36106, United States

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Montgomery, Alabama, 36109, United States

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Pelham, Alabama, 35124, United States

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Tuscaloosa, Alabama, 35404, United States

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Tuscaloosa, Alabama, 35406, United States

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Jonesboro, Arkansas, 72401, United States

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Clovis, California, 93611, United States

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Fresno, California, 93710, United States

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Fresno, California, 93720, United States

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San Diego, California, 92103, United States

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San Diego, California, 92117, United States

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San Diego, California, 92123, United States

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Bridgeport, Connecticut, 06606, United States

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Wichita, Kansas, 67208, United States

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Louisville, Kentucky, 40207, United States

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New Orleans, Louisiana, 70115, United States

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Kalamazoo, Michigan, 49008, United States

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Portage, Michigan, 49024, United States

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Richland, Michigan, 49083, United States

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Three Rivers, Michigan, 49093, United States

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Jefferson City, Missouri, 65101, United States

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Missoula, Montana, 59801, United States

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Missoula, Montana, 59804, United States

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Charlote, North Carolina, 28210, United States

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Charlotte, North Carolina, 28210, United States

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Cincinnati, Ohio, 45241, United States

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Cincinnati, Ohio, 45242, United States

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Dayton, Ohio, 45402, United States

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Dayton, Ohio, 45406, United States

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Eugene, Oregon, 97401, United States

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Eugene, Oregon, 97404, United States

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Medford, Oregon, 97504, United States

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Morrisville, Pennsylvania, 19067, United States

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Norristown, Pennsylvania, 19401, United States

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Plymouth Meeting, Pennsylvania, 19462, United States

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Orangeburg, South Carolina, 29118, United States

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Nashville, Tennessee, 37203, United States

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Amarillo, Texas, 79109, United States

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Amarillo, Texas, 79119, United States

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Amarillo, Texas, 79124, United States

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Bryan, Texas, 77802, United States

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El Paso, Texas, 79902, United States

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Houston, Texas, 77015, United States

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Houston, Texas, 77074, United States

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Pasadena, Texas, 77505, United States

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San Antonio, Texas, 78205, United States

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San Antonio, Texas, 78224, United States

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San Antonio, Texas, 78229, United States

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Wichita Falls, Texas, 76302, United States

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Wichita Falls, Texas, 76309, United States

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Murray, Utah, 84107, United States

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Salt Lake City, Utah, 84102, United States

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Salt Lake City, Utah, 84109, United States

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Salt Lake City, Utah, 84121, United States

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Buenos Aires, 1427, Argentina

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Santiago, Chile

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Bo. Aranjuez, Provincia de San José, Costa Rica

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Escazú, Provincia de San José, Costa Rica

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Guadalupe, Provincia de San José, Costa Rica

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San José, Provincia de San José, Costa Rica

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Uruca, Provincia de San José, Costa Rica

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Prague, 100 34, Czechia

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Prague, 128 08, Czechia

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Prague, 150 06, Czechia

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Tallinn, 13419, Estonia

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Tartu, 51003, Estonia

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Rostock, 18055, Germany

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Bangalore, Karnataka, 560 034, India

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Kochi, Kerala, 682 026, India

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Lucknow, Uttar Pradesh, 226020, India

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Vilnius, LT-2005, Lithuania

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Vilnius, LT-2600, Lithuania

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Chihuahua City, Chihuahua, 31020, Mexico

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Bielsko-Biala, Poland

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Katowice, 40-027, Poland

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Lublin, 20-718, Poland

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Poznan, 60-355, Poland

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Moscow, 117049, Russia

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Moscow, 125206, Russia

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Smolensk, 214019, Russia

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Bratislava, Slovakia, Slovakia

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Košice, Slovakia, 040 11, Slovakia

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Martin, Slovakia, 036 01, Slovakia

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Related Links

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

MeSH Terms

Conditions

Maxillary Sinusitis

Interventions

Azithromycin; Levofloxacin

Condition Hierarchy (Ancestors)

Sinusitis; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 26, 2008
• Study Start: January 1, 2003
• Study Completion: February 1, 2004
• Last Updated: May 11, 2011

Record last verified: 2011-05

Locations

ES (2); CL (1); US (59); IN (3); CO (5); CZ (3); AR (1); LI (2); DE (1); ME (1); PL (4); RU (3); SL (3)