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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00087490
First received: July 9, 2004
Last updated: June 29, 2012
Last verified: June 2012
Results First Received: June 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Skin/Soft Tissue Infections
Methicillin Resistant Staphylococcus Aureus (MRSA)
Interventions: Drug: linezolid
Drug: vancomycin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Linezolid Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 milligram (mg). Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented methicillin-resistant Staphylococcus aureus (MRSA) bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Vancomycin Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg per kilogram per dose (15 mg/kg/dose) over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.

Participant Flow:   Overall Study
    Linezolid     Vancomycin  
STARTED     544     533  
Treated     537     515  
COMPLETED     286     264  
NOT COMPLETED     258     269  
Death                 6                 4  
Adverse Event                 3                 8  
Lack of Efficacy                 0                 2  
Protocol Violation or (/) Unspecified                 214                 201  
Lost to Follow-Up/participant withdrawal                 28                 36  
Randomized but not treated                 7                 18  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Linezolid Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Vancomycin Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
Total Total of all reporting groups

Baseline Measures
    Linezolid     Vancomycin     Total  
Number of Participants  
[units: participants]
  537     515     1052  
Age  
[units: Years]
Mean ± Standard Deviation
  49.7  ± 17.6     49.4  ± 17.2     49.5  ± 17.4  
Gender  
[units: Participants]
     
Female     232     200     432  
Male     305     315     620  



  Outcome Measures
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1.  Primary:   Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population   [ Time Frame: EOS (6 to 28 days after the last dose of study drug) ]

2.  Secondary:   Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population   [ Time Frame: EOT (within 72 hours of last dose of study drug) ]

3.  Secondary:   Clinical Outcome in Participants With Baseline MRSA at EOS for Modified-Intent to Treat (mITT) Population   [ Time Frame: EOS (6 to 28 days after the last dose of study drug) ]

4.  Secondary:   Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population   [ Time Frame: EOT (within 72 hours of last dose of study drug) ]

5.  Secondary:   Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population   [ Time Frame: EOS (6 to 28 days after the last dose of study drug) ]

6.  Secondary:   Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population   [ Time Frame: EOT (within 72 hours of last dose of study drug) ]

7.  Secondary:   Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population   [ Time Frame: EOS (6 to 28 days after the last dose of study drug) ]

8.  Secondary:   Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population   [ Time Frame: EOT (within 72 hours of last dose of study drug) ]

9.  Secondary:   Number of Participants With Clinical Signs and Symptoms at EOT and EOS for PP Population   [ Time Frame: EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug) ]

10.  Secondary:   Number of Participants With Clinical Signs and Symptoms at EOT and EOS for mITT Population   [ Time Frame: EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug) ]

11.  Secondary:   Duration of Hospital Stay for PP Population   [ Time Frame: Baseline up to EOS (6 to 28 days after the last dose of study drug) ]

12.  Secondary:   Duration of Hospital Stay for mITT Population   [ Time Frame: Baseline up to EOS (6 to 28 days after the last dose of study drug) ]

13.  Secondary:   Duration of Intravenous Therapy for PP Population   [ Time Frame: Baseline up to EOS (6 to 28 days after the last dose of study drug) ]

14.  Secondary:   Duration of Intravenous Therapy for mITT Population   [ Time Frame: Baseline up to EOS (6 to 28 days after the last dose of study drug) ]

15.  Secondary:   Number of Participants Using Medical Resources   [ Time Frame: Baseline up to EOS (6 to 28 days after the last dose of study drug) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Comparing duration of intravenous (IV) therapy for linezolid (LZD) and vancomycin (VAN) in study, participants in LZD group had option to switch to oral therapy while those in VAN group had to remain on IV therapy until completion of study treatment.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00087490     History of Changes
Other Study ID Numbers: A5951002
Study First Received: July 9, 2004
Results First Received: June 29, 2012
Last Updated: June 29, 2012
Health Authority: United States: Food and Drug Administration