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A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Clarithromycin Extended Release for the Treatment of Pneumonia in Adult Patients

NCT ID: NCT00643227

Last Updated: 2008-03-26

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

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-03-31

Brief Summary

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The study was performed to confirm that a single, 2.0 g oral dose of azithromycin sustained release (SR) at least as effective as 7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily, when used to treat adults with mild to moderate community acquired pneumonia (CAP), and that both treatments were safe.

Detailed Description

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Conditions

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Pneumonia

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

clarithromycin extended release (ER)

Intervention Type DRUG

7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily

2

Group Type EXPERIMENTAL

azithromycin SR

Intervention Type DRUG

Single, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily

Interventions

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clarithromycin extended release (ER)

7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily

Intervention Type DRUG

azithromycin SR

Single, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Outpatients with a diagnosis of pneumonia, as demonstrated by a productive cough and at least 2 of the following signs and symptoms: rales and/or evidence of pulmonary consolidation; dyspnea or tachypnea; elevated body temperature; or elevated total peripheral white blood cell count (WBC \>10,000/mm3) or greater than 15% immature neutrophils were included. Patients were to have a chest radiograph demonstrating evidence of a new infiltrate or consolidation, and a Modified Fine Risk score of ≤ 70 (Fine Class I and II).

Exclusion Criteria

Patients who were treated with any systemic antibiotic of greater than 1 dose or 1 combination dose (such as cephalosporin and macrolide) within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; were hospitalized in the previous 14 days or had an infection acquired in the hospital, and who were residents of a long-term care facility were excluded.
Minimum Eligible Age

16 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

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Haleyville, Alabama, United States

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Montgomery, Alabama, United States

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Montgomery, Alabama, United States

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Tallassee, Alabama, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Tempe, Arizona, United States

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La Jolla, California, United States

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San Diego, California, United States

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Orlando, Florida, United States

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Boise, Idaho, United States

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Boise, Idaho, United States

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Boise, Idaho, United States

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Boise, Idaho, United States

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Boise, Idaho, United States

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Meridian, Idaho, United States

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Nampa, Idaho, United States

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Chalmette, Louisiana, United States

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New Orleans, Louisiana, United States

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New Orleans, Louisiana, United States

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Butte, Montana, United States

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Holmdel, New Jersey, United States

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Clemmons, North Carolina, United States

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Salisbury, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Charleston, South Carolina, United States

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Summerville, South Carolina, United States

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Milan, Tennessee, 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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Taylorsville, Utah, United States

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West Jordan, Utah, United States

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Casper, Wyoming, United States

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Tandil, Buenos Aires, Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Edmonton, Alberta, Canada

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Coquitlam, British Columbia, Canada

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St. John's, Newfoundland and Labrador, Canada

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Toronto, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Drummondville, Quebec, Canada

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Granby, Quebec, Canada

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Longueuil, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Saint-Jérôme, Quebec, Canada

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Ste-Foy, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Tallinn, , Estonia

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Tallinn, , Estonia

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Tallinn, , Estonia

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Tartu, , Estonia

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Hyderabad, Andhra Pradesh, India

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Bangalore, Karnataka, India

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Elamakkara, Cochin, Kerala, India

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Pune, Maharashtra, India

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Ludhiana, Punjab, India

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Coimbatore, Tamil Nadu, India

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Kaunas, , Lithuania

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Vilnius, , Lithuania

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Smolensk, , Russia

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, ,

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Countries

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United States Argentina Canada Estonia India Lithuania Russia

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661075&StudyName=A%20Multicenter%2C%20Randomized%2C%20Double-Blind%2C%20Double-Dummy%20Trial%20of%20Azithromycin%20SR%20Compared%20with%20Clarithromycin%20Extended%20Release%20for%20the%20Tre

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

Other Identifiers

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A0661075

Identifier Type: -

Identifier Source: org_study_id