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

NCT ID: NCT00643409

Last Updated: 2011-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

541 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-02-29

Brief Summary

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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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Detailed Description

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Conditions

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Maxillary Sinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

placebo

Intervention Type OTHER

placebo

2

Group Type EXPERIMENTAL

levofloxacin

Intervention Type DRUG

levofloxacin 500 mg capsule by mouth qd x 10 days

placebo

Intervention Type OTHER

placebo

Interventions

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

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

Intervention Type DRUG

placebo

placebo

Intervention Type OTHER

levofloxacin

levofloxacin 500 mg capsule by mouth qd x 10 days

Intervention Type DRUG

placebo

placebo

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Alabaster, Alabama, United States

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Hueytown, Alabama, United States

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Montgomery, Alabama, United States

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Montgomery, Alabama, United States

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Pelham, Alabama, United States

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Tuscaloosa, Alabama, United States

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Tuscaloosa, Alabama, United States

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Jonesboro, Arkansas, United States

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Clovis, California, United States

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Fresno, California, United States

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Fresno, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Bridgeport, Connecticut, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Kalamazoo, Michigan, United States

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Portage, Michigan, United States

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Richland, Michigan, United States

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Three Rivers, Michigan, United States

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Jefferson City, Missouri, United States

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Missoula, Montana, United States

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Missoula, Montana, United States

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Charlote, North Carolina, United States

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Charlotte, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Dayton, Ohio, United States

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Eugene, Oregon, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Morrisville, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Plymouth Meeting, Pennsylvania, United States

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Orangeburg, South Carolina, United States

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Nashville, Tennessee, United States

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Amarillo, Texas, United States

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Amarillo, Texas, United States

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Amarillo, Texas, United States

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Bryan, Texas, United States

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El Paso, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Pasadena, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Wichita Falls, Texas, United States

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Wichita Falls, Texas, United States

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Murray, Utah, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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Buenos Aires, , 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, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Tallinn, , Estonia

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Tartu, , Estonia

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Rostock, , Germany

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Bangalore, Karnataka, India

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Kochi, Kerala, India

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Lucknow, Uttar Pradesh, India

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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Chihuahua City, Chihuahua, Mexico

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Bielsko-Biala, , Poland

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Katowice, , Poland

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Lublin, , Poland

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Poznan, , Poland

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Moscow, , Russia

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Moscow, , Russia

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Smolensk, , Russia

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Bratislava, Slovakia, Slovakia

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Košice, Slovakia, Slovakia

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Martin, Slovakia, Slovakia

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, ,

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Countries

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United States Argentina Chile Costa Rica Czechia Estonia Germany India Lithuania Mexico Poland Russia Slovakia

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661078&StudyName=A%20Multicenter%2C%20Randomized%2C%20Double-Blind%2C%20Double-Dummy%20Trial%20of%20Azithromycin%20SR%20Compared%20with%20Levofloxacin%20for%20the%20Treatment%20of%20Sinus%20I

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

Other Identifiers

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A0661078

Identifier Type: -

Identifier Source: org_study_id

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