Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)

NCT00087490

Last updated date
Study Location
Pfizer Investigational Site
Montgomery, Alabama, 36106, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Skin/Soft Tissue Infections, Methicillin Resistant Staphylococcus Aureus (MRSA)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and female subjects with signs or symptoms consistent with infection, and if available, laboratory findings consistent with staphylococcal infection (e.g., Gram stain and culture results).

- Signs and symptoms consistent with infection

- Infection suspected to be due to Methicillin Resistant Staphylococcus Aureus

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Subjects who were treated with a previous antibiotic (systemic or topical) with MRSA
activity (other than linezolid or vancomycin) for more than 24 hours and treatment
extended into the 72 hour period prior to the first dose of study drug, unless
documented to be a treatment failure (72 hours of treatment and not responding).


- Subjects with uncomplicated skin or superficial skin structure infection such as
superficial/simple cellulitis, impetiginous lesion, furuncle, or simple abscess that
only need surgical drainage for cure.


- Subjects excluded with necrotizing fasciitis, gas gangrene, osteomyelitis

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Skin/Soft Tissue Infections, Methicillin Resistant Staphylococcus Aureus (MRSA)Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
NCT00087490
  1. Montgomery, Alabama
  2. Tucson, Arizona
  3. Los Angeles, California
  4. Palm Springs, California
  5. Rancho Mirage, California
  6. San Pedro, California
  7. Santa Fe Springs, California
  8. Sylmar, California
  9. Torrance, California
  10. Torrance, California
  11. Torrance, California
  12. Denver, Colorado
  13. Denver, Colorado
  14. Hartford, Connecticut
  15. Hartford, Connecticut
  16. New Haven, Connecticut
  17. New Haven, Connecticut
  18. Atlantis, Florida
  19. Melbourne, Florida
  20. Miami, Florida
  21. Pensacola, Florida
  22. Atlanta, Georgia
  23. Augusta, Georgia
  24. Blue Ridge, Georgia
  25. Honolulu, Hawaii
  26. Honolulu, Hawaii
  27. Chicago, Illinois
  28. Decatur, Illinois
  29. Hines, Illinois
  30. Maywood, Illinois
  31. North Chicago, Illinois
  32. Northlake, Illinois
  33. Springfield, Illinois
  34. Springfield, Illinois
  35. Iowa City, Iowa
  36. Louisville, Kentucky
  37. Louisville, Kentucky
  38. Louisville, Kentucky
  39. New Orleans, Louisiana
  40. Baltimore, Maryland
  41. Baltimore, Maryland
  42. Baltimore, Maryland
  43. Boston, Massachusetts
  44. West Roxbury, Massachusetts
  45. East Lansing, Michigan
  46. Lansing, Michigan
  47. Minneapolis, Minnesota
  48. Mpls, Minnesota
  49. St. Paul, Minnesota
  50. Butte, Montana
  51. Lincoln, Nebraska
  52. Lincoln, Nebraska
  53. Somers Point, New Jersey
  54. Stony Brook, New York
  55. Winston-Salem, North Carolina
  56. Akron, Ohio
  57. Akron, Ohio
  58. Akron, Ohio
  59. Columbus, Ohio
  60. Columbus, Ohio
  61. Toledo, Ohio
  62. Philadelphia, Pennsylvania
  63. Philadelphia, Pennsylvania
  64. Philadelphia, Pennsylvania
  65. West Reading, Pennsylvania
  66. Ducktown, Tennessee
  67. Jackson, Tennessee
  68. Dallas, Texas
  69. Dallas, Texas
  70. Dallas, Texas
  71. Fort Worth, Texas
  72. Forth Worth, Texas
  73. Houston, Texas
  74. St. George, Utah
  75. St. George, Utah
  76. Tacoma, Washington
  77. Loma Hermosa, Buenos Aires
  78. Buenos Aires,
  79. Buenos Aires,
  80. Cordoba,
  81. Charleroi,
  82. Gent,
  83. Montigny-le-Tilleul,
  84. São José do Rio Preto, SP
  85. São Paulo, SP
  86. Providencia, Santiago
  87. Santiago,
  88. Barranquilla, Atlantico
  89. Bogota, Cundinamarca
  90. Floridablanca, Santander
  91. Genova,
  92. Napoli,
  93. Roma,
  94. Roma,
  95. Udine,
  96. Varese,
  97. Kuala Lumpur,
  98. Kuala Lumpur,
  99. Mexico, DF
  100. Guadalajara, Jalisco
  101. Monterrey, Nuevo Leon
  102. Pragal, Almada
  103. Amadora,
  104. Coimbra,
  105. Lisboa,
  106. Lisboa,
  107. Moscow,
  108. Moscow,
  109. Smolensk,
  110. Singapore,
  111. Kuilsriver, Western Province
  112. Johannesburg,
  113. Parow,
  114. Pretoria,
  115. Pretoria,
  116. Cordoba,
  117. Gerona,
  118. Sevilla,
  119. Winchester, Hampshire
  120. Edinburgh,
  121. Leeds,
  122. Ciudad Bolívar, Estado Bolívar
  123. Distrito Capital, Estado Miranda
  124. Distrito Capital, Estado Miranda
  125. Maracaibo, Estado Zulia
  126. Valencia,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
Official Title  ICMJE Linezolid in the Treatment of Subjects With Complicated Skin and Soft Tissue Infections Proven to be Due to Methicillin-Resistant Staphylococcus Aureus
Brief Summary To determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Skin/Soft Tissue Infections
  • Methicillin Resistant Staphylococcus Aureus (MRSA)
Intervention  ICMJE
  • Drug: linezolid
  • Drug: vancomycin
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2008)
1077
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female subjects with signs or symptoms consistent with infection, and if available, laboratory findings consistent with staphylococcal infection (e.g., Gram stain and culture results).
  • Signs and symptoms consistent with infection
  • Infection suspected to be due to Methicillin Resistant Staphylococcus Aureus

Exclusion Criteria:

  • Subjects who were treated with a previous antibiotic (systemic or topical) with MRSA activity (other than linezolid or vancomycin) for more than 24 hours and treatment extended into the 72 hour period prior to the first dose of study drug, unless documented to be a treatment failure (72 hours of treatment and not responding).
  • Subjects with uncomplicated skin or superficial skin structure infection such as superficial/simple cellulitis, impetiginous lesion, furuncle, or simple abscess that only need surgical drainage for cure.
  • Subjects excluded with necrotizing fasciitis, gas gangrene, osteomyelitis
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Brazil,   Chile,   Colombia,   Italy,   Malaysia,   Mexico,   Portugal,   Russian Federation,   Singapore,   South Africa,   Spain,   United Kingdom,   United States,   Venezuela
Removed Location Countries Germany,   Ireland
 
Administrative Information
NCT Number  ICMJE NCT00087490
Other Study ID Numbers  ICMJE A5951002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP