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

History of Changes

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

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.

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:

Itani KM, Biswas P, Reisman A, Bhattacharyya H, Baruch AM. Clinical efficacy of oral linezolid compared with intravenous vancomycin for the treatment of methicillin-resistant Staphylococcus aureus-complicated skin and soft tissue infections: a retrospective, propensity score-matched, case-control analysis. Clin Ther. 2012 Aug;34(8):1667-73.e1. Epub 2012 Jul 6.

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

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