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

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ClinicalTrials.gov Identifier: NCT01170221
Recruitment Status : Completed
First Posted : July 27, 2010
Results First Posted : September 3, 2014
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics LLC

Study Description
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Brief Summary:

This is a randomized, double-blind, double dummy, multicenter Phase 3 study of oral TR-701 FA 200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults.

Approximately 75 to 100 sites globally will participate in this study. Patients with an ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be randomized 1:1 to study treatment


Condition or disease Intervention/treatment Phase
Skin and Subcutaneous Tissue Bacterial Infections Drug: TR-701 FA Drug: Linezolid Phase 3

Detailed Description:
The primary objective is to determine the noninferiority in the early clinical response rate of 6 day oral TR-701 FA compared with that of 10-day oral linezolid treatment at the 48-72 Hour Visit in the ITT analysis set in patients with ABSSSI.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 667 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of 6-Day Oral TR-701 Free Acid and 10-Day Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Actual Study Start Date : August 15, 2010
Actual Primary Completion Date : September 30, 2011
Actual Study Completion Date : September 30, 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: TR-701 FA
TR0-701 FA 200 mg tablets once a day for six days followed by 4 days of placebo
 Drug: TR-701 FA
Oral TR-701 FA 200 mg once daily for six days followed by four days of placebo.
Other Names:
  • Tedizolid Phosphate
  • TR-700 active moiety
Active Comparator: Linezolid
Linezolid 600 mg tablets oral twice a day for 10 days
 Drug: Linezolid
Oral Linezolid 600 mg twice daily for 10 days
Other Names:
  • Trade name = Zyvox
  • Generic name = linezolid


Outcome Measures
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Primary Outcome Measures :
  1. Early Clinical Response Rate [ Time Frame: 48-72 hours ]
    Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C


Secondary Outcome Measures :
  1. Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit. [ Time Frame: Day 11 ]
    Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C.

  2. Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets [ Time Frame: EOT Day 11 ]
    Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C

  3. 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) ]
    Clinical success defined as resolution/near resolution of most disease-specific signs and symptoms, absence/near resolution of systemic signs of infection, if present at baseline, no new signs, symptoms, or complications attributable to the ABSSSIs so no further antibiotic therapy was required for the treatment of the primary lesion.

  4. To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set [ Time Frame: Post-Treatment Evaluation (7-14 days after the End of Therapy) ]
    Clinical success defined as resolution/near resolution of most disease-specific signs and symptoms, absence/near resolution of systemic signs of infection, no new signs, symptoms, or complications attributable to the ABSSSIs so no further antibiotic therapy was required for the treatment of the primary lesion.

  5. Investigator's Assessment of Clinical Response at the 48-72 Hour Visit [ Time Frame: 48-72 Hour Visit ]
    Clinical improvement was defined as improvement in overall clinical status.

  6. Investigator's Assessment of Clinical Response at the Day 7 Visit [ Time Frame: Day 7 ]
    Clinical improvement was defined as improvement in overall clinical status.

  7. Change From Baseline in Patient-reported Pain, by Study Visit [ Time Frame: Multiple ]
    0=no pain, 10=worst pain Only 1 visit per participant for Day 4-6, only 1 visit for Day 7-9, and only 1 visit for Day 10-13.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (ABSSSI)
  • Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections

Exclusion Criteria:

  • Uncomplicated skin infections
  • Severe sepsis or septic shock
  • ABSSSI solely due to gram-negative pathogens
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170221


Locations
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Sponsors and Collaborators
Trius Therapeutics LLC
Investigators
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Study Director: Philippe G Prokocimer, MD Trius Therapeutics
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Trius Therapeutics LLC
ClinicalTrials.gov Identifier: NCT01170221    
Other Study ID Numbers: 1986-009
TR701-112 ( Other Identifier: TriusRX Unique ID )
First Posted: July 27, 2010    Key Record Dates
Results First Posted: September 3, 2014
Last Update Posted: August 29, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Keywords provided by Trius Therapeutics LLC:
ABSSSI
Tedizolid Phosphate
TR-701
Acute Bacterial Skin and Skin Structure Infections
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Skin Diseases
Linezolid
 Tedizolid phosphate
Tedizolid
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action