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
  Purpose

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.


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

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
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Trius Therapeutics, Inc.:

Primary Outcome Measures:
  • The Early Clinical Response Rate [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
    Responder: No increase in lesion surface area from baseline.


Secondary Outcome Measures:
  • Clinical Response at the End of Therapy Visit [ Time Frame: Day 11 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Clinical improvement defined as improvement in overall clinical status.

  • Investigator's Assessment of Clinical Response at the Day-7 Visit [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Clinical improvement defined as improvement in overall clinical status.

  • Change From Baseline in Patient-reported Pain, by Study Visit [ Time Frame: Multiple ] [ Designated as safety issue: No ]
    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.


Enrollment: 666
Study Start Date: September 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TR-701 FA
• TR-701 FA IV followed by TR-701 FA tablets
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
Active Comparator: Linezolid
• Linezolid IV followed by Linezolid Tablets
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421511

  Show 118 Study Locations
Sponsors and Collaborators
Trius Therapeutics, Inc.
Investigators
Study Director: Philippe G Prokocimer, MD Trius Therapeutics
  More Information

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

Keywords provided by Trius Therapeutics, Inc.:
ABSSSI
Tedizolid Phosphate
TR-701
Acute Bacterial Skin and Skin Structure Infections

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacterial Infections
Linezolid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014