TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01421511
First received: August 19, 2011
Last updated: August 31, 2014
Last verified: August 2014
Results First Received: July 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Skin and Subcutaneous Tissue Bacterial Infections
Interventions: Drug: TR-701 FA
Drug: Linezolid

  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
Tedizolid Phosphate IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
Linezolid IV to oral linezolid 600 mg twice daily for 10 days.

Participant Flow:   Overall Study
    Tedizolid Phosphate     Linezolid  
STARTED     332     334  
COMPLETED     313     306  
NOT COMPLETED     19     28  
Lost to Follow-up                 11                 14  
Randomized but didn't receive study drug                 1                 7  
Physician Decision                 0                 1  
Withdrawal by Subject                 6                 5  
Death                 1                 1  



  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.
All randomized participants

Reporting Groups
  Description
Tedizolid Phosphate IV to oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo.
Linezolid IV to oral linezolid 600 mg twice daily for 10 days.
Total Total of all reporting groups

Baseline Measures
    Tedizolid Phosphate     Linezolid     Total  
Number of Participants  
[units: participants]
  332     334     666  
Age  
[units: years]
Mean ± Standard Deviation
  45.6  ± 15.79     45.6  ± 15.57     45.6  ± 15.67  
Gender  
[units: participants]
     
Female     107     120     227  
Male     225     214     439  



  Outcome Measures
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1.  Primary:   The Early Clinical Response Rate   [ Time Frame: 48-72 hours ]

2.  Secondary:   Clinical Response at the End of Therapy Visit   [ Time Frame: Day 11 ]

3.  Secondary:   Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set   [ Time Frame: End of Therapy Day 11 ]

4.  Secondary:   Investigator’s Assessment of Clinical Success at the Post Treatment Evaluation Visit   [ Time Frame: Post-Treatment Evaluation (7-14 days after the End of Therapy) ]

5.  Secondary:   Investigator's Assessment of Clinical Success of the Post Therapy Evaluation Visit in Clinically Evaluable-Post Treatment Evaluation Analysis Set.   [ Time Frame: Post-Treatment Evaluation (7-14 days after the End of Therapy) ]

6.  Secondary:   Investigator's Assessment of Clinical Response at the 48-72 Hour Visit   [ Time Frame: 48-72 Hours ]

7.  Secondary:   Investigator's Assessment of Clinical Response at the Day-7 Visit   [ Time Frame: Day 7 ]

8.  Secondary:   Change From Baseline in Patient-reported Pain, by Study Visit   [ Time Frame: Multiple ]


  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
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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:
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: Philippe Prokocimer, MD
Organization: Cubist Pharmaceuticals, Inc.
phone: 858-452-0370 ext 241
e-mail: philippe.prokocimer@cubist.com


No publications provided


Responsible Party: Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01421511     History of Changes
Other Study ID Numbers: TR701-113
Study First Received: August 19, 2011
Results First Received: July 15, 2014
Last Updated: August 31, 2014
Health Authority: United States: Food and Drug Administration