Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)

NCT00084266

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233, United States
Contact
1-800-718-1021

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1-800-718-1021

By email

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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

- Hospitalized male and female subjects with clinically documented nosocomial pneumonia proven to be due to methicillin-resistant staphylococcus aureus.

- Chest X-ray at baseline/screen or within 48 hours of treatment consistent with the diagnosis of pneumonia.

- Suitable sputum specimen defined as having less than 10 squamous epithelial cells and greater or equal 25 leukocytes or have a culture taken by an invasive technique within 24 hours of study entry.

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 with MRSA activity (other than
linezolid or vancomycin) for more than 48 hours, unless documented to be a treatment
failure (72 hours of treatment and not responding).


- Subjects with severe neutropenia (<500 cells/mm3)


- Subjects with hypersensitivity to oxazolidinones or vancomycin.

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Methicillin Resistant Staphylococcus Aureus (MRSA)Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
NCT00084266
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Huntsville, Alabama
  5. Montgomery, Alabama
  6. Montgomery, Alabama
  7. Phoenix, Arizona
  8. Los Angeles, California
  9. Orange, California
  10. Redlands, California
  11. Sacramento, California
  12. San Diego, California
  13. San Diego, California
  14. San Francisco, California
  15. Denver, Colorado
  16. Denver, Colorado
  17. Denver, Colorado
  18. Newark, Delaware
  19. Washington, District of Columbia
  20. Washington, District of Columbia
  21. Brandon, Florida
  22. Fort Lauderdale, Florida
  23. Gainesville, Florida
  24. Jacksonville, Florida
  25. Jackson, Florida
  26. Miami, Florida
  27. Orlando, Florida
  28. Orlando, Florida
  29. Tampa, Florida
  30. Augusta, Georgia
  31. Augusta, Georgia
  32. Decatur, Georgia
  33. Decatur, Georgia
  34. Honolulu, Hawaii
  35. Chicago, Illinois
  36. North Chicago, Illinois
  37. Oak Park, Illinois
  38. Springfield, Illinois
  39. Springfield, Illinois
  40. Springfield, Illinois
  41. New Albany, Indiana
  42. Hazard, Kentucky
  43. Lexington, Kentucky
  44. Louisville, Kentucky
  45. Louisville, Kentucky
  46. Baltimore, Maryland
  47. Boston, Massachusetts
  48. Boston, Massachusetts
  49. Boston, Massachusetts
  50. Boston, Massachusetts
  51. Springfield, Massachusetts
  52. Ann Arbor, Michigan
  53. Detroit, Michigan
  54. Detroit, Michigan
  55. Detroit, Michigan
  56. Saint Louis, Missouri
  57. St. Loius, Missouri
  58. St. Louis, Missouri
  59. Omaha, Nebraska
  60. Las Vegas, Nevada
  61. Reno, Nevada
  62. Reno, Nevada
  63. Hackensack, New Jersey
  64. Albany, New York
  65. Bronx, New York
  66. Brooklyn, New York
  67. Buffalo, New York
  68. New York, New York
  69. New York, New York
  70. New York, New York
  71. Rochester, New York
  72. Rochester, New York
  73. Greensboro, North Carolina
  74. Fargo, North Dakota
  75. Fargo, North Dakota
  76. Cincinnati, Ohio
  77. Cincinnati, Ohio
  78. Columbus, Ohio
  79. Columbus, Ohio
  80. Columbus, Ohio
  81. Columbus, Ohio
  82. Sylvania, Ohio
  83. Toledo, Ohio
  84. Toledo, Ohio
  85. Portland, Oregon
  86. Portland, Oregon
  87. Abington, Pennsylvania
  88. Allentown, Pennsylvania
  89. Bethlehem, Pennsylvania
  90. Philadelphia, Pennsylvania
  91. Pittsburgh, Pennsylvania
  92. Providence, Rhode Island
  93. Charleston, South Carolina
  94. Sioux Falls, South Dakota
  95. Sioux Falls, South Dakota
  96. Sioux Falls, South Dakota
  97. Nashville, Tennessee
  98. Nashville, Tennessee
  99. Houston, Texas
  100. Irving, Texas
  101. San Antonio, Texas
  102. San Antonio, Texas
  103. San Marcos, Texas
  104. Sequin, Texas
  105. Temple, Texas
  106. Murray, Utah
  107. Richmond, Virginia
  108. Winchester, Virginia
  109. Buenos Aires,
  110. Brugge,
  111. Brussels,
  112. Gent,
  113. Liege 1,
  114. Salvador, BA
  115. Sao Jose do Rio Preto, SP
  116. São Paulo, SP
  117. Santiago, Región Metropolitana
  118. Santiago, RM
  119. Santiago,
  120. Barranquilla, Atlantico
  121. Bogota, Bogota. DC
  122. Bogota, Cundinamarca
  123. Ibague, Tolima
  124. Paris, Cedex 18
  125. Marseille Cedex 20,
  126. Paris,
  127. Saint Etienne Cedex 02,
  128. Goettingen,
  129. Leipzig,
  130. Leipzig,
  131. Kifisia, Athens
  132. Athens,
  133. Crete,
  134. Thessaloniki,
  135. Hong Kong,
  136. Seoul,
  137. Seoul,
  138. Seoul,
  139. Seoul,
  140. Seoul,
  141. Kuala Lumpur,
  142. Kuala Lumpur,
  143. Mexico, DF
  144. Guadalajara, Jalisco
  145. Monterrey/Col. Mitras Centro, Nuevo Léon
  146. Ciudad Madero, Tamaulipas
  147. Bytom,
  148. Katowice,
  149. Krakow,
  150. Krakow,
  151. Almada,
  152. Coimbra,
  153. Lisboa,
  154. Senhora da Hora,
  155. Ponce,
  156. San Juan,
  157. Moscow, Russia
  158. Moscow,
  159. Moscow,
  160. Moscow,
  161. Moscow,
  162. Moscow,
  163. Auckland Park,
  164. Bloefontein,
  165. Soweto,
  166. Badalona, Barcelona
  167. Barcelona,
  168. Barcelona,
  169. Madrid,
  170. Kaohsiung,
  171. Pan-Chiao,
  172. Taichung,
  173. Taipei,
  174. Ankara,
  175. Plymouth, Devon
  176. Edinburgh,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
Official Title  ICMJE Linezolid In The Treatment Of Subjects With Nosocomial Pneumonia Proven To Be Due To Methicillin-Resistant Staphylococcus Aureus
Brief Summary To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to Methicillin Resistant Staphylococcus Aureus (MRSA) in adult subjects. Subjects entered in to the study will have proven healthcare-associated methicillin-resistant Staphylococcus aureus pneumonia which will be treated with either linezolid or vancomycin.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Methicillin Resistant Staphylococcus Aureus (MRSA)
Intervention  ICMJE
  • Drug: linezolid (Zyvox)
    Subjects to receive either linezolid 600 mg IV (Intravenous) or PO (orally) q 12 h (every 12 hours) for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
    Other Name: Zyvox, linezolid
  • Drug: vancomycin
    Subjects to receive vancomycin 15mg/kg IV (Intravenous) q12h (every 12 hours), adjusted for renal function, for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
Study Arms  ICMJE
  • Experimental: 1
    Subjects receiving linezolid for the treatment phase of the study
    Intervention: Drug: linezolid (Zyvox)
  • Active Comparator: 2
    Subjects receiving vancomycin for the treatment phase of the study
    Intervention: Drug: vancomycin
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: March 7, 2011)
1225
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hospitalized male and female subjects with clinically documented nosocomial pneumonia proven to be due to methicillin-resistant staphylococcus aureus.
  • Chest X-ray at baseline/screen or within 48 hours of treatment consistent with the diagnosis of pneumonia.
  • Suitable sputum specimen defined as having less than 10 squamous epithelial cells and greater or equal 25 leukocytes or have a culture taken by an invasive technique within 24 hours of study entry.

Exclusion Criteria:

  • Subjects who were treated with a previous antibiotic with MRSA activity (other than linezolid or vancomycin) for more than 48 hours, unless documented to be a treatment failure (72 hours of treatment and not responding).
  • Subjects with severe neutropenia (<500 cells/mm3)
  • Subjects with hypersensitivity to oxazolidinones or vancomycin.
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,   France,   Germany,   Greece,   Hong Kong,   Korea, Republic of,   Malaysia,   Mexico,   Poland,   Portugal,   Puerto Rico,   Russian Federation,   South Africa,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries Italy,   Singapore,   Venezuela
 
Administrative Information
NCT Number  ICMJE NCT00084266
Other Study ID Numbers  ICMJE A5951001
Has Data Monitoring Committee No
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 January 2012

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