New Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)

April 25, 2011 updated by: Pfizer

Linezolid in the Treatment of Penicillin-Resistant Streptococcus Pneumoniae Pneumonia: An Open-Label, Non-Comparator Study

This study will treat patients who have a community-acquired pneumonia that is due to a specific bacteria (S. pneumoniae)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

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

  • Slovakia
      • Bratislava, Slovakia
        • Research Center
  • Spain
      • Barcelona, Spain, 08025
        • Research Center
      • Barcelona, Spain, 08036
        • Research Center
      • Barcelona, Spain, 08907
        • Research Center
      • Girona, Spain, 17007
        • Research Center
      • Madrid, Spain, 28034
        • Research Center
      • Madrid, Spain, 28046
        • Research Center
      • Madrid, Spain, 28923
        • Research Center
    • Barcelona
      • Mataro, Barcelona, Spain, 08304
        • Research Center
    • Madrid
      • Mostoles, Madrid, Spain, 28935
        • Research Center
  • Taiwan
      • Kaohsiung, Taiwan
        • Research Center
      • Taoyuan, Taiwan
        • Research Center
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Research Center
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Research Center
      • Naples, Florida, United States, 34102
        • Research Center
    • Georgia
      • Savannah, Georgia, United States, 31416
        • Research Center
    • Illinois
      • Springfield, Illinois, United States, 62701
        • Research Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Research Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Research Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48197
        • Research Center
      • Royal Oak, Michigan, United States, 48073
        • Research Center
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Research Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Research Center
      • Newark, New Jersey, United States, 07102
        • Research Center
      • Somerville, New Jersey, United States, 08876
        • Research Center
    • New York
      • Staten Island, New York, United States, 10305
        • Research Center
      • Stony Brook, New York, United States, 11794
        • Research Center
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Research Center
      • Zanesville, Ohio, United States, 43701
        • Research Center
    • Pennsylvania
      • Fleetwood, Pennsylvania, United States, 19522
        • Research Center
      • Hershey, Pennsylvania, United States, 17033
        • Research Center
    • South Carolina
      • Ninety Six, South Carolina, United States, 29666
        • Research Center
      • Spartanburg, South Carolina, United States, 29307
        • Research Center
    • Tennessee
      • Harrogate, Tennessee, United States, 37752-0078
        • Research Center
      • Jackson, Tennessee, United States, 38301
        • Research Center
      • Knoxville, Tennessee, United States, 37920
        • Research Center
      • Memphis, Tennessee, United States, 38104-3499
        • Research Center
      • Memphis, Tennessee, United States, 38120
        • Research Center
      • Memphis, Tennessee, United States, 38163
        • Research Center
      • Nashville, Tennessee, United States, 37205
        • Research Center
    • Texas
      • Dallas, Texas, United States, 75235
        • Research Center
      • Houston, Texas, United States, 77030
        • Research Center
      • Lubbock, Texas, United States, 79430
        • Research Center
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • Research Center
      • Richmond, Virginia, United States, 23294
        • Research Center
    • Washington
      • Seattle, Washington, United States, 98108
        • Research Center

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

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

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.

Inclusion Criteria:

  • Patients must have the signs and symptoms of pneumonia, with a chest xray showing a pneumonia.
  • The patient must have S. pneumoniae (a specific bacteria) growing in sputum or blood to continue treatment.

Exclusion Criteria:

  • Patients cannot have taken more than one day of another antibiotic before entering this study.
  • Patients with HIV and a low CD4 count are 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To assess the microbiologic efficacy of linezolid in the treatment of patients with pneumonia caused by penicillin-resistant Streptococcus pneumoniae (PRSP).
Additionally, microbiologic efficacy will be assessed in all pneumonia patients infected with S pneumoniae SP) and in those infected with penicillin-sensitive (PSSP) and penicillin-intermediate (PISP) S pneumoniae.

Secondary Outcome Measures

Outcome Measure
To assess clinical efficacy and safety in pneumonia patients infected with S pneumoniae.

Collaborators and Investigators

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

Sponsor

Pfizer

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

December 1, 2001

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

May 2, 2002

First Submitted That Met QC Criteria

May 2, 2002

First Posted (Estimate)

May 3, 2002

Study Record Updates

Last Update Posted (Estimate)

April 26, 2011

Last Update Submitted That Met QC Criteria

April 25, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M12600071
  • A5951056

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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