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

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ClinicalTrials.gov Identifier: NCT01421511
Recruitment Status : Completed
First Posted : August 22, 2011
Results First Posted : September 8, 2014
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics LLC

Tracking Information
First Submitted Date  ICMJE August 19, 2011
First Posted Date  ICMJE August 22, 2011
Results First Submitted Date  ICMJE July 15, 2014
Results First Posted Date  ICMJE September 8, 2014
Last Update Posted Date August 29, 2018
Actual Study Start Date  ICMJE September 15, 2011
Actual Primary Completion Date January 10, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2014)
The Early Clinical Response Rate [ Time Frame: 48-72 hours ]
Responder: No increase in lesion surface area from baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: August 19, 2011)
determine the noninferiority (NI) in the early clinical response rate [ Time Frame: 48-72 hours ]
afebrile with cessation of spread of the erythema, edema, and/or induration or reduction in the size (length, width, and area) of erythema, edema, and/or induration from baseline of the primary ABSSSI lesion and nonresponder
Change History Complete list of historical versions of study NCT01421511 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2014)
  • Clinical Response at the End of Therapy Visit [ Time Frame: Day 11 ]
    Responder: No increase in lesion surface area from baseline.
  • 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 ]
    Responder: No increase in lesion surface area from baseline.
  • 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 disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, and no further antibiotic therapy required for treatment of primary ABSSSI lesion.
  • 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) ]
    Clinical success defined as resolution/near resolution of disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, no new signs, symptoms or complications attributable to the ABSSSI and no further antibiotic therapy required for treatment of primary ABSSSI lesion.
  • Investigator's Assessment of Clinical Response at the 48-72 Hour Visit [ Time Frame: 48-72 Hours ]
    Clinical improvement defined as improvement in overall clinical status.
  • Investigator's Assessment of Clinical Response at the Day-7 Visit [ Time Frame: Day 7 ]
    Clinical improvement defined as improvement in overall clinical status.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Official Title  ICMJE A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of IV to Oral 6-Day TR-701 Free Acid and IV to Oral 10-Day Linezolid for the Treatment of ABSSSI
Brief Summary

This is a randomized, double-blind, double-dummy, multicenter, global Phase 3 study of IV to oral TR-701 FA 200 mg once daily for 6 days versus IV to oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults. Patients are to start treatment with at least 2 IV doses and may receive IV therapy for the entire treatment duration.

Approximately 100 to 140 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.

Detailed Description The primary objective is to determine the noninferiority (NI) in the early clinical response rate of intravenous (IV) to oral 6 day TR-701 free acid (FA) compared with that of IV to oral 10-day linezolid treatment at 48-72 hours after the first infusion of study drug in the intent-to-treat (ITT) analysis set in patients with acute bacterial skin and skin structure infections (ABSSSI).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Skin and Subcutaneous Tissue Bacterial Infections
Intervention  ICMJE
  • Drug: TR-701 FA
    • TR-701 FA 200 mg once daily in 250 mL sterile saline for injection as a 60 minute IV infusion
    • TR-701 FA Tablets, 200 mg, orally once daily
  • Drug: Linezolid
    • Linezolid 600 mg IV Injection twice daily in 300 mL sterile saline for injection as a 60 minute IV infusion
    • Linezolid Tablets, 600 mg, orally every 12 hours
Study Arms  ICMJE
  • Experimental: TR-701 FA
    • TR-701 FA IV followed by TR-701 FA tablets
    Intervention: Drug: TR-701 FA
  • Active Comparator: Linezolid
    • Linezolid IV followed by Linezolid Tablets
    Intervention: Drug: Linezolid
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: January 30, 2013)
666
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2011)
658
Actual Study Completion Date  ICMJE January 10, 2013
Actual Primary Completion Date January 10, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients requiring IV antibiotic therapy and with systemic signs of infection diagnosed with 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
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,   Australia,   Brazil,   Germany,   Mexico,   New Zealand,   Poland,   Russian Federation,   South Africa,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01421511
Other Study ID Numbers  ICMJE 1986-010
TR701-113 ( Other Identifier: TriusRX Unique ID )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Trius Therapeutics LLC
Study Sponsor  ICMJE Trius Therapeutics LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Philippe G Prokocimer, MD Trius Therapeutics
PRS Account Trius Therapeutics LLC
Verification Date July 2018

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