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Linezolid in the Treatment of Subjects with Nosocomial Pneumonia Proven to be due to Methicillin-Resistant Staphylococcus Aureus - Article


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Linezolid Oral Suspension

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Clinical Trial: Linezolid in the Treatment of Subjects with Nosocomial Pneumonia Proven to be due to Methicillin-Resistant Staphylococcus Aureus

This study is currently recruiting patients.

Sponsored by: Pfizer
Information provided by: Pfizer

Purpose

Linezolid is the first of a new class of antibiotics with a unique mechanism of action against Methicillin-Resistant Staphylococcus Aureus (MRSA). This is a Phase IV, double-blinded, randomized study for patients with hospital acquired pneumonia proven to be caused by MRSA. Patients will be treated with linezolid or vancomycin for a minimum of 7 days and up to a maximum of 14 days. The primary objective of this study is to compare the clinical efficacy of linezolid to vancomycin in treatment of pneumonia due to MRSA.

Condition Treatment or Intervention Phase
Pneumonia
 Drug: Linezolid
 Drug: Vancomycin
Phase IV

MedlinePlus related topics:  Pneumonia

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 

Expected Total Enrollment:  1200

Study start: June 2004

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

  • Hospitalized adults aged 18 years or older
  • Hospital acquired pneumonia (acquired 48 hours after hospitalization)
  • Chest X-ray or CT scan consistent with the diagnosis of pneumonia
  • Subjects with severe neutropenia (<500 cells/mm3) are excluded
  • Subjects with hypersensitivity to linezolid or vancomycin are excluded

Location and Contact Information

Call:      1-734-622-7600    ClinicalTrials.gov@Pfizer.com

Alabama
      Pfizer Investigational Site, Montgomery,  Alabama,  36111,  United States; Recruiting

      Pfizer Investigational Site, Montgomery,  Alabama,  36116,  United States; Recruiting

Arizona
      Pfizer Investigational Site, Phoenix,  Arizona,  85008,  United States; Recruiting

California
      Pfizer Investigational Site, Redlands,  California,  92373,  United States; Recruiting

      Pfizer Investigational Site, Los Angeles,  California,  90033,  United States; Recruiting

District of Columbia
      Pfizer Investigational Site, Washington,  District of Columbia,  20037,  United States; Recruiting

Florida
      Pfizer Investigational Site, Clearwater,  Florida,  33756,  United States; Recruiting

      Pfizer Investigational Site, Atlantis,  Florida,  33462,  United States; Recruiting

      Pfizer Investigational Site, Clearwater,  Florida,  33756,  United States; Recruiting

      Pfizer Investigational Site, Tampa,  Florida,  33607,  United States; Recruiting

      Pfizer Investigational Site, Miami,  Florida,  33136,  United States; Recruiting

Georgia
      Pfizer Investigational Site, Augusta,  Georgia,  30909,  United States; Recruiting

      Pfizer Investigational Site, Augusta,  Georgia,  30912,  United States; Recruiting

Illinois
      Pfizer Investigational Site, Springfield,  Illinois,  62703,  United States; Recruiting

      Pfizer Investigational Site, Springfield,  Illinois,  62701,  United States; Recruiting

      Pfizer Investigational Site, Springfield,  Illinois,  62702,  United States; Recruiting

Indiana
      Pfizer Investigational Site, Indianapolis,  Indiana,  46202,  United States; Recruiting

Kentucky
      Pfizer Investigational Site, Louisville,  Kentucky,  40206,  United States; Recruiting

Maryland
      Pfizer Investigational Site, Baltimore,  Maryland,  21201,  United States; Recruiting

Massachusetts
      Pfizer Investigational Site, Boston,  Massachusetts,  02111,  United States; Recruiting

      Pfizer Investigational Site, Springfield,  Massachusetts,  01199,  United States; Recruiting

Michigan
      Pfizer Investigational Site, Detroit,  Michigan,  48201,  United States; Recruiting

      Pfizer Investigational Site, Detroit,  Michigan,  48210,  United States; Recruiting

      Pfizer Investigational Site, Detroit,  Michigan,  48202,  United States; Recruiting

      Pfizer Investigational Site, Detroit,  Michigan,  48201,  United States; Recruiting

Missouri
      Pfizer Investigational Site, Springfield,  Missouri,  65807,  United States; Recruiting

      Pfizer Investigational Site, Springfield,  Missouri,  65804,  United States; Recruiting

      Pfizer Investigational Site, St. Louis,  Missouri,  63110,  United States; Recruiting

      Pfizer Investigational Site, Springfield,  Missouri,  65804,  United States; Recruiting

New York
      Pfizer Investigational Site, Bronx,  New York,  10467,  United States; Recruiting

      Pfizer Investigational Site, Buffalo,  New York,  14215,  United States; Recruiting

      Pfizer Investigational Site, New York,  New York,  10021,  United States; Recruiting

      Pfizer Investigational Site, Albany,  New York,  12208,  United States; Recruiting

      Pfizer Investigational Site, Rochester,  New York,  14642,  United States; Recruiting

      Pfizer Investigational Site, Brooklyn,  New York,  11215,  United States; Recruiting

North Carolina
      Pfizer Investigational Site, Greensboro,  North Carolina,  27401,  United States; Recruiting

      Pfizer Investigational Site, Greenville,  North Carolina,  27834,  United States; Recruiting

      Pfizer Investigational Site, Greensboro,  North Carolina,  27401,  United States; Recruiting

Ohio
      Pfizer Investigational Site, Toledo,  Ohio,  43614,  United States; Recruiting

Oregon
      Pfizer Investigational Site, Portland,  Oregon,  97213,  United States; Recruiting

Pennsylvania
      Pfizer Investigational Site, Allentown,  Pennsylvania,  18103,  United States; Recruiting

      Pfizer Investigational Site, Philadelphia,  Pennsylvania,  19140,  United States; Recruiting

      Pfizer Investigational Site, Philadelphia,  Pennsylvania,  19107,  United States; Recruiting

South Dakota
      Pfizer Investigational Site, Sioux Falls,  South Dakota,  57117,  United States; Recruiting

      Pfizer Investigational Site, Sioux Falls,  South Dakota,  57104,  United States; Recruiting

      Pfizer Investigational Site, Sioux Falls,  South Dakota,  57105,  United States; Recruiting

Tennessee
      Pfizer Investigational Site, Nashville,  Tennessee,  37232,  United States; Recruiting

      Pfizer Investigational Site, Jackson,  Tennessee,  38301,  United States; Recruiting

Texas
      Pfizer Investigational Site, San Marcos,  Texas,  78666,  United States; Recruiting

      Pfizer Investigational Site, Sequin,  Texas,  78155,  United States; Recruiting

Chile
      Pfizer Investigational Site, Santiago,  Chile; Recruiting

Colombia, Bogota DC
      Pfizer Investigational Site, Bogota,  Bogota DC,  Colombia; Recruiting

Puerto Rico
      Pfizer Investigational Site, San Juan,  00921,  Puerto Rico; Recruiting

More Information

Study ID Numbers:  A5951001
Record last reviewed:  March 2005
Last Updated:  March 15, 2005
Record first received:  June 9, 2004
ClinicalTrials.gov Identifier:  NCT00084266
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 18, 2008



Page Updated: June 1, 2005
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