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NCT00643409 Clinical Trial

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

Maxillary Sinusitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00643409
Other study ID # A0661078
Secondary ID
Status Completed
Phase Phase 3
First received March 19, 2008
Last updated May 10, 2011
Start date January 2003
Est. completion date February 2004

Study information
Verified date May 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 541
Est. completion date February 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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
Drug:
• levofloxacin
levofloxacin 500 mg capsule by mouth qd x 10 days
Other:
• placebo
placebo

Locations
Country Name City State
Argentina Pfizer Investigational Site Buenos Aires
Chile Pfizer Investigational Site Santiago
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 Pfizer Investigational Site Unknown Heredia
Czech Republic Pfizer Investigational Site Prague 10
Czech Republic Pfizer Investigational Site Prague 2
Czech Republic Pfizer Investigational Site Prague 5
Estonia Pfizer Investigational Site Tallinn
Estonia Pfizer Investigational Site Tartu
Estonia Pfizer Investigational Site Unknown Parsti vald/Viljandimaa
Germany Pfizer Investigational Site Rostock
India Pfizer Investigational Site Bangalore Karnataka
India Pfizer Investigational Site Kochi Kerala
India Pfizer Investigational Site Lucknow Uttar Pradesh
Lithuania Pfizer Investigational Site Vilnius
Lithuania Pfizer Investigational Site Vilnius
Mexico Pfizer Investigational Site Chihuahua
Poland Pfizer Investigational Site Bielsko-Biala
Poland Pfizer Investigational Site Katowice
Poland Pfizer Investigational Site Lublin
Poland Pfizer Investigational Site Poznan
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Smolensk
Slovakia Pfizer Investigational Site Bratislava
Slovakia Pfizer Investigational Site Kosice
Slovakia Pfizer Investigational Site Martin
United States Pfizer Investigational Site Alabaster Alabama
United States Pfizer Investigational Site Amarillo Texas
United States Pfizer Investigational Site Amarillo Texas
United States Pfizer Investigational Site Amarillo Texas
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Bridgeport Connecticut
United States Pfizer Investigational Site Bryan Texas
United States Pfizer Investigational Site Charlote North Carolina
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Clovis California
United States Pfizer Investigational Site Dayton Ohio
United States Pfizer Investigational Site Dayton Ohio
United States Pfizer Investigational Site El Paso Texas
United States Pfizer Investigational Site Eugene Oregon
United States Pfizer Investigational Site Eugene Oregon
United States Pfizer Investigational Site Fresno California
United States Pfizer Investigational Site Fresno California
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Hueytown Alabama
United States Pfizer Investigational Site Jefferson City Missouri
United States Pfizer Investigational Site Jonesboro Arkansas
United States Pfizer Investigational Site Kalamazoo Michigan
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Medford Oregon
United States Pfizer Investigational Site Missoula Montana
United States Pfizer Investigational Site Missoula Montana
United States Pfizer Investigational Site Montgomery Alabama
United States Pfizer Investigational Site Montgomery Alabama
United States Pfizer Investigational Site Morrisville Pennsylvania
United States Pfizer Investigational Site Murray Utah
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site Norristown Pennsylvania
United States Pfizer Investigational Site Orangeburg South Carolina
United States Pfizer Investigational Site Pasadena Texas
United States Pfizer Investigational Site Pelham Alabama
United States Pfizer Investigational Site Plymouth Meeting Pennsylvania
United States Pfizer Investigational Site Portage Michigan
United States Pfizer Investigational Site Richland Michigan
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Three Rivers Michigan
United States Pfizer Investigational Site Tuscaloosa Alabama
United States Pfizer Investigational Site Tuscaloosa Alabama
United States Pfizer Investigational Site Wichita Kansas
United States Pfizer Investigational Site Wichita Falls Texas
United States Pfizer Investigational Site Wichita Falls Texas

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Chile,  Costa Rica,  Czech Republic,  Estonia,  Germany,  India,  Lithuania,  Mexico,  Poland,  Russian Federation,  Slovakia, 

Outcome
Type Measure Description Time frame Safety issue
Primary sponsor assessment of clinical response for the Clinical per Protocol population Test of Cure (TOC) visit (Day 17-24) No
Secondary sponsor assessment of clinical response by baseline pathogen for the Bacteriological per Protocol population EOT visit and TOC visit No
Secondary investigator assessment of clinical response for the Clinical per Protocol population TOC visit No
Secondary bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population TOC visit No
Secondary summary of baseline susceptibilities Study endpoint No
Secondary adverse events Continuous Yes
Secondary laboratory abnormalities during and post-treatment Yes
Secondary sponsor assessment of clinical response for the Clinical per Protocol population End of Treatment (EOT) visit (Day 11-13) No
Secondary sponsor assessment of clinical response for the remaining study populations EOT visit and TOC visit No
See also
  Status Clinical Trial Phase
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Completed NCT00683371 - Microarray Analysis of Sinus Samples From Patients With and Without Chronic Rhinosinusitis N/A
Completed NCT00236652 - A Study Evaluating the Safety and Efficacy of Treating Sinus Infection With Levofloxacin 750 mg for 5 Days. Phase 3
Recruiting NCT06130176 - Single-step Functional Sinus Endoscopy and Transoral Surgery N/A
Recruiting NCT04241016 - Endoscopic Sinus Surgery in Recurrent Acute Rhinosinusitis N/A
Not yet recruiting NCT03083392 - Endosseous Oroantral Port for Minimal Intervention in Treating Chronic Sinusitis N/A
Completed NCT00668304 - Trial to Evaluate Time to Symptom Relief and Elimination of Infecting Bacteria in Treating Sinusitis With Avelox Phase 4
Recruiting NCT04645511 - Balloon Sinuplasty Efficiency in Maxillary Rhinosinusitis. N/A
Not yet recruiting NCT02931604 - Study Designed to Clinically Evaluate Sinus Wash Device Prototypes N/A
Terminated NCT00245440 - Study to Measure the Impact of Antibiotics on Bacterial Flora in Adults With Acute Sinusitis Phase 4
Completed NCT00537563 - AMS VS MOXI Ketek vs Avelox in AMS Phase 3
Completed NCT00249210 - A Study of the Safety and Effectiveness of Levofloxacin Compared With Amoxicillin/Clavulanate Potassium in the Treatment of Adults With Rapid Onset of Severe Inflammation/Infection of the Sinuses Phase 3
Completed NCT01032174 - Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis N/A

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