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

March 19, 2008 updated by: Pfizer

A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Clarithromycin Extended Release for the Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

504

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

        • Pfizer Investigational Site
      • Buenos Aires, Argentina, 1427
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1120AAF
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1272AAA
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1282AFQ
        • Pfizer Investigational Site
    • Buenos Aires
      • Tandil, Buenos Aires, Argentina, B7000AXD
        • Pfizer Investigational Site
    • Alberta
      • Edmonton, Alberta, Canada, T5A 4L8
        • Pfizer Investigational Site
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3P4
        • Pfizer Investigational Site
    • Newfoundland and Labrador
      • St-John's, Newfoundland and Labrador, Canada, A1E 2E2
        • Pfizer Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M9W 4L6
        • Pfizer Investigational Site
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Pfizer Investigational Site
      • Drummondville, Quebec, Canada, J2B 1H8
        • Pfizer Investigational Site
      • Granby, Quebec, Canada, J2G 8Z9
        • Pfizer Investigational Site
      • Longueuil, Quebec, Canada, J4N 1E1
        • Pfizer Investigational Site
      • Pointe Claire, Quebec, Canada, H9R 4S3
        • Pfizer Investigational Site
      • St Jerome, Quebec, Canada, J7Z 5T3
        • Pfizer Investigational Site
      • Ste-Foy, Quebec, Canada, G1V 4G5
        • Pfizer Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 3H3
        • Pfizer Investigational Site
      • Tallinn, Estonia, 13419
        • Pfizer Investigational Site
      • Tallinn, Estonia, 10617
        • Pfizer Investigational Site
      • Tallinn, Estonia, 13619
        • Pfizer Investigational Site
      • Tartu, Estonia, 51014
        • Pfizer Investigational Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 033
        • Pfizer Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 034
        • Pfizer Investigational Site
    • Kerala
      • Elamakkara, Cochin, Kerala, India, 682 026
        • Pfizer Investigational Site
    • Maharashtra
      • Pune, Maharashtra, India, 411 053
        • Pfizer Investigational Site
    • Punjab
      • Ludhiana, Punjab, India, 141 001
        • Pfizer Investigational Site
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641 022
        • Pfizer Investigational Site
      • Kaunas, Lithuania, LT-3000
        • Pfizer Investigational Site
      • Vilnius, Lithuania, LT-2010
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 105077
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 105229
        • Pfizer Investigational Site
      • Moscow, Russian Federation
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 107066
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 119048
        • Pfizer Investigational Site
      • Smolensk, Russian Federation, 214019
        • Pfizer Investigational Site
    • Alabama
      • Birmingham, Alabama, United States, 35215
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35242
        • Pfizer Investigational Site
      • Haleyville, Alabama, United States, 35565
        • Pfizer Investigational Site
      • Montgomery, Alabama, United States, 36106
        • Pfizer Investigational Site
      • Montgomery, Alabama, United States, 36109
        • Pfizer Investigational Site
      • Tallassee, Alabama, United States, 36078
        • Pfizer Investigational Site
    • Arizona
      • Mesa, Arizona, United States, 85201
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85014
        • Pfizer Investigational Site
      • Tempe, Arizona, United States, 85282
        • Pfizer Investigational Site
    • California
      • La Jolla, California, United States, 92037
        • Pfizer Investigational Site
      • San Diego, California, United States, 92128
        • Pfizer Investigational Site
    • Florida
      • Orlando, Florida, United States, 32806
        • Pfizer Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83704
        • Pfizer Investigational Site
      • Boise, Idaho, United States, 83703
        • Pfizer Investigational Site
      • Boise, Idaho, United States, 83706
        • Pfizer Investigational Site
      • Boise, Idaho, United States, 83709
        • Pfizer Investigational Site
      • Boise, Idaho, United States, 83713
        • Pfizer Investigational Site
      • Meridian, Idaho, United States, 83642
        • Pfizer Investigational Site
      • Nampa, Idaho, United States, 83651
        • Pfizer Investigational Site
    • Louisiana
      • Chalmette, Louisiana, United States, 70043
        • Pfizer Investigational Site
      • New Orleans, Louisiana, United States, 70112
        • Pfizer Investigational Site
      • New Orleans, Louisiana, United States, 70128
        • Pfizer Investigational Site
    • Montana
      • Butte, Montana, United States, 59701
        • Pfizer Investigational Site
    • New Jersey
      • Holmdel, New Jersey, United States, 07733
        • Pfizer Investigational Site
    • North Carolina
      • Clemmons, North Carolina, United States, 27012
        • Pfizer Investigational Site
      • Salisbury, North Carolina, United States, 28144
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Pfizer Investigational Site
      • Summerville, South Carolina, United States, 29485
        • Pfizer Investigational Site
    • Tennessee
      • Milan, Tennessee, United States, 38358
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84109
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84121
        • Pfizer Investigational Site
      • Taylorsville, Utah, United States, 84118
        • Pfizer Investigational Site
      • West Jordan, Utah, United States, 84088
        • Pfizer Investigational Site
    • Wyoming
      • Casper, Wyoming, United States, 82601
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily
Experimental: 2
Single, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sponsor assessment of clinical response (clinical cure rate) in the Clinical Per Protocol population
Time Frame: Test of Cure (TOC) visit (Day 14-21)
Test of Cure (TOC) visit (Day 14-21)

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: Continuous
Continuous
bacteriologic response (eradication rate) in the Bacteriological Per Protocol population
Time Frame: TOC visit
TOC visit
investigator assessment of clinical response in the Clinical Per Protocol population
Time Frame: TOC visit
TOC visit
sponsor assessment of clinical response by baseline pathogen
Time Frame: End of Treatment (EOT) visit (Day 8-11) and TOC visit
End of Treatment (EOT) visit (Day 8-11) and TOC visit
sponsor assessment of clinical response in the non-primary population
Time Frame: EOT visit and TOC visit
EOT visit and TOC visit
sponsor assessment of clinical responses in the Clinical Per Protocol population
Time Frame: EOT visit and Long-Term Follow-Up (LTFU) visit (Day 28-35)
EOT visit and Long-Term Follow-Up (LTFU) visit (Day 28-35)
susceptibilities of baseline pathogens
Time Frame: Study endpoint
Study endpoint
vital signs
Time Frame: Baseline, On-Treatment (OT) visit (Day 3-5), and TOC visit
Baseline, On-Treatment (OT) visit (Day 3-5), and TOC visit
physical examination
Time Frame: Baseline
Baseline
clinical laboratory assessments (blood chemistry and hematology)
Time Frame: Baseline and TOC visit
Baseline and TOC visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion (Actual)

March 1, 2004

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

March 26, 2008

Last Update Submitted That Met QC Criteria

March 19, 2008

Last Verified

March 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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