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Linezolid in the Treatment of Complicated Skin and Soft Tissue due to Methicillin-Resistant Staphylococcus Aureus - Article


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Linezolid Injection

Zyvox Injection


Clinical Trial: Linezolid in the Treatment of Complicated Skin and Soft Tissue due to Methicillin-Resistant Staphylococcus Aureus

This study is currently recruiting patients.

Sponsored by: Pfizer
Information provided by: Pfizer

Purpose

This is a Phase IV randomized, multi-center, open label trial to compare the clinical safety and efficacy of linezolid to vancomycin in the treatment of complicated skin and soft tissue infections due to methicillin-resistant staphylococcus aureus in adult subjects hospitalized for at least one day.

Condition Treatment or Intervention Phase
Staphylococcal Skin Infections
Soft Tissue Infections
  Drug: Linezolid
 Drug: Vancomycin
 Phase IV

MedlinePlus related topics:  Bacterial Infections;   Skin Diseases;   Staphylococcal Infections

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment

Official Title: Linezolid in the Treatment of Subjects with Complicated Skin and Soft Tissue Proven to be due to Methicillin-Resistant Staphylococcus Aureus

Further Study Details: 

Expected Total Enrollment:  1200

Study start: August 2004

Eligibility

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

Criteria

  • Hospitalized male/female subjects at least 18 years of age
  • Signs and symptoms consistent with infection
  • Infection suspected to be due to Methicillin Resistant Staphylococcus Aureus
  • Subjects excluded with necrotizing fasciitis, gas gangrene, osteomyelitis
  • Subjects excluded if treated with a previous antibiotic with known activity against Methicillin Resistant Staphylococcus Aureus for more than 24 hours

Location and Contact Information

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

Alabama
      Pfizer Investigational Site, Montgomery,  Alabama,  36106,  United States; Recruiting

California
      Pfizer Investigational Site, Palm Springs,  California,  92262,  United States; Recruiting

      Pfizer Investigational Site, Rancho Mirage,  California,  92270,  United States; Recruiting

Colorado
      Pfizer Investigational Site, Denver,  Colorado,  80205,  United States; Recruiting

      Pfizer Investigational Site, Denver,  Colorado,  80218,  United States; Recruiting

Connecticut
      Pfizer Investigational Site, New Haven,  Connecticut,  06520,  United States; Recruiting

      Pfizer Investigational Site, New Haven,  Connecticut,  06515,  United States; Recruiting

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

      Pfizer Investigational Site, Pensacola,  Florida,  32501,  United States; Recruiting

Georgia
      Pfizer Investigational Site, Blue Ridge,  Georgia,  30513,  United States; Recruiting

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

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

      Pfizer Investigational Site, North Chicago,  Illinois,  60064,  United States; Recruiting

      Pfizer Investigational Site, Decatur,  Illinois,  62526,  United States; Recruiting

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

Michigan
      Pfizer Investigational Site, St. Joseph,  Michigan,  49103,  United States; Recruiting

Minnesota
      Pfizer Investigational Site, Minneapolis,  Minnesota,  55422,  United States; Recruiting

Montana
      Pfizer Investigational Site, Butte,  Montana,  59701,  United States; Recruiting

New York
      Pfizer Investigational Site, Poughkeepsie,  New York,  12601,  United States; Recruiting

North Carolina
      Pfizer Investigational Site, Winston Salem,  North Carolina,  27103,  United States; Recruiting

Ohio
      Pfizer Investigational Site, Akron,  Ohio,  44304,  United States; Recruiting

      Pfizer Investigational Site, Columbus,  Ohio,  43215,  United States; Recruiting

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

Tennessee
      Pfizer Investigational Site, Ducktown,  Tennessee,  37326,  United States; Recruiting

Utah
      Pfizer Investigational Site, St. George,  Utah,  84770,  United States; Recruiting

Argentina
      Pfizer Investigational Site, Buenos Aires,  C1425DQK,  Argentina; Recruiting

      Pfizer Investigational Site, Buenos Aires,  Argentina; Recruiting

      Pfizer Investigational Site, Cordoba,  5000,  Argentina; Recruiting

Argentina, Buenos Aires
      Pfizer Investigational Site, Loma Hermosa,  Buenos Aires,  1653,  Argentina; Recruiting

More Information

Study ID Numbers:  A5951002
Record last reviewed:  March 2005
Last Updated:  March 15, 2005
Record first received:  July 9, 2004
ClinicalTrials.gov Identifier:  NCT00087490
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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