New Antibiotic to Treat Patients With Community-Acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia) - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00035269

Purpose

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

Condition	Intervention	Phase
Pneumonia, Pneumococcal Community Acquired Infections Gram-Positive Bacterial Infections	Drug: Antibiotic	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Linezolid in the Treatment of Penicillin-Resistant Streptococcus Pneumoniae Pneumonia: An Open-Label, Non-Comparator Study

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Bacterial Infections Pneumonia

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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:

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

Enrollment:	230
Study Start Date:	December 2001
Estimated Study Completion Date:	May 2003

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035269

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Locations

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

Sponsors and Collaborators

Pfizer

More Information

Additional Information:

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	M12600071, A5951056
Study First Received:	May 2, 2002
Last Updated:	July 2, 2007
ClinicalTrials.gov Identifier:	NCT00035269 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Pharmacia

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Communicable Diseases
Pneumonia, Pneumococcal
Infection
Pneumococcal Infections
Pharmacologic Actions
Anti-Bacterial Agents
Gram-Positive Bacterial Infections

Respiratory Tract Diseases
Respiratory Tract Infections
Streptococcal Infections
Therapeutic Uses
Lung Diseases
Pneumonia, Bacterial
Community-Acquired Infections
Pneumonia

ClinicalTrials.gov processed this record on November 27, 2009