A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Mild to Moderate Pneumonia in Adult Patients

March 19, 2008 updated by: Pfizer

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

The study was performed to see if a single, 2.0-g oral dose of azithromycin sustained release (SR) was at least as effective as a 7-day regimen of levofloxacin (500 mg once daily) for the treatment of mild to moderate community-acquired pneumonia, and to assess the efficacy and safety of both treatment regimens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

468

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

  • Canada
    • British Columbia
      • Langley, British Columbia, Canada, V3A 4H9
        • Pfizer Investigational Site
    • Ontario
      • Hawkesbury, Ontario, Canada, K6A 1A1
        • Pfizer Investigational Site
      • Kitchener, Ontario, Canada, N2C 2N9
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M9W 4L6
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3H 1V4
        • Pfizer Investigational Site
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Pfizer Investigational Site
      • Ste-foy, Quebec, Canada, G1V 4P9
        • Pfizer Investigational Site
      • Victoriaville, Quebec, Canada, G6P 6N2
        • Pfizer Investigational Site
    • Saskatchewan
      • North Battleford, Saskatchewan, Canada, S9A 0V6
        • Pfizer Investigational Site
      • Saskatoon, Saskatchewan, Canada, S7K 7H9
        • Pfizer Investigational Site
  • Chile
    • Santiago
      • Providencia, Santiago, Chile
        • Pfizer Investigational Site
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560054
        • Pfizer Investigational Site
      • Bangalore, Karnataka, India, 560052
        • Pfizer Investigational Site
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India
        • Pfizer Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 012
        • Pfizer Investigational Site
      • Nagpur, Maharashtra, India
        • Pfizer Investigational Site
    • Tamilnadu
      • Chennai, Tamilnadu, India, 600116
        • Pfizer Investigational Site
      • Vellore, Tamilnadu, India, 632002
        • Pfizer Investigational Site
  • Lithuania
      • Alytus, Lithuania, LT-4580
        • Pfizer Investigational Site
      • Kaunas, Lithuania, LT-3021
        • Pfizer Investigational Site
      • Klaipeda, Lithuania, LT-5800
        • Pfizer Investigational Site
  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Pfizer Investigational Site
  • Peru
    • Lima
      • San Isidro, Lima, Peru
        • Pfizer Investigational Site
      • San Miguel, Lima, Peru
        • Pfizer Investigational Site
  • Russian Federation
      • 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
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85014
        • Pfizer Investigational Site
    • California
      • San Luis Obispo, California, United States, 93401
        • Pfizer Investigational Site
      • San Mateo, California, United States, 94403
        • Pfizer Investigational Site
    • Colorado
      • Highlands Ranch, Colorado, United States, 80130
        • Pfizer Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19702
        • Pfizer Investigational Site
    • Florida
      • Kissimmee, Florida, United States, 34741
        • Pfizer Investigational Site
      • Merrit Island, Florida, United States, 32953
        • Pfizer Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Pfizer Investigational Site
      • Evansville, Indiana, United States, 47712
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States, 46254
        • Pfizer Investigational Site
    • Iowa
      • Dubuque, Iowa, United States, 52001
        • Pfizer Investigational Site
    • Kansas
      • Pratt, Kansas, United States, 67124
        • Pfizer Investigational Site
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Pfizer Investigational Site
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • Pfizer Investigational Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Pfizer Investigational Site
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • Pfizer Investigational Site
    • Nebraska
      • Elkhorn, Nebraska, United States, 68022
        • Pfizer Investigational Site
      • Omaha, Nebraska, United States, 68144
        • Pfizer Investigational Site
    • New Mexico
      • Rio Rancho, New Mexico, United States, 87124
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28262
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28210
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28209
        • Pfizer Investigational Site
      • Hickory, North Carolina, United States, 28601
        • Pfizer Investigational Site
    • Oklahoma
      • Yukon, Oklahoma, United States, 73099
        • Pfizer Investigational Site
    • Pennsylvania
      • Downingtown, Pennsylvania, United States, 19335
        • Pfizer Investigational Site
      • King of Prussia, Pennsylvania, United States, 19406
        • Pfizer Investigational Site
      • Morrisville, Pennsylvania, United States, 19067
        • Pfizer Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Pfizer Investigational Site
    • Tennessee
      • Dyersburg, Tennessee, United States, 38024
        • Pfizer Investigational Site
    • Texas
      • Lake Jackson, Texas, United States, 77566
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84121
        • Pfizer Investigational Site
    • Washington
      • Walla Walla, Washington, United States, 99362
        • Pfizer Investigational Site
    • Wisconsin
      • Menomonee Falls, Wisconsin, United States, 53051
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with clinical evidence of mild to moderate community-acquired pneumonia, including cough productive of sputum and a diagnosis of pneumonia, were included.

Exclusion Criteria:

Key exclusion criteria were treatment with any systemic antibiotic of greater than one dose or one combination dose within the previous 7 days, previously diagnosed conditions which tend to mimic or complicate the course and the evaluation of the evaluation process (e.g., bronchiectasis, lung abscess or empyema, active tuberculosis, pulmonary malignancy, cystic fibrosis, post-obstructive pneumonia), hospitalization in the previous 14 days or infection acquired in the hospital, and residents of a long-term care facility.

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
Other: placebo
placebo
Drug: azithromycin sustained release
azithromycin SR 2.0 g by mouth in the form of a slurry for 1 dose
Experimental: 2
Other: placebo
placebo
Drug: levofloxacin
500 mg (two 250 mg capsules) by mouth once daily for 7 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: Continuous
Continuous
bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population
Time Frame: TOC visit
TOC visit
summary of baseline susceptibilities
Time Frame: Study endpoint
Study endpoint
sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population
Time Frame: EOT visit and TOC visit
EOT visit and TOC visit
laboratory abnormalities
Time Frame: Baseline and TOC visit
Baseline and TOC visit
sponsor assessment of clinical response (cure or failure) in the remaining study populations
Time Frame: EOT visit and TOC visit
EOT visit and TOC visit
investigator assessment of clinical response (cure or failure) in the Clinical Per Protocol population
Time Frame: TOC visit
TOC visit
sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population
Time Frame: End of Treatment (EOT) visit (Days 8-11)
End of Treatment (EOT) visit (Days 8-11)
sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population
Time Frame: Long-Term Follow-Up (LTFU) visit (Days 28-35)
Long-Term Follow-Up (LTFU) visit (Days 28-35)

Collaborators and Investigators

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

Sponsor

Pfizer

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.

Helpful Links

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

April 1, 2003

Study Completion (Actual)

April 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

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0661103

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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