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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01170221
First received: July 23, 2010
Last updated: August 31, 2014
Last verified: August 2014
  Purpose

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 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 6-Day Oral TR-701 Free Acid and 10-Day Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Resource links provided by NLM:


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

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


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

  • 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 ] [ Designated as safety issue: No ]
    Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C

  • 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 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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Investigator's Assessment of Clinical Response at the 48-72 Hour Visit [ Time Frame: 48-72 Hour Visit ] [ Designated as safety issue: No ]
    Clinical improvement was 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 was 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: 667
Study Start Date: August 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01170221

  Show 84 Study Locations
Sponsors and Collaborators
Trius Therapeutics, Inc.
Investigators
Study Director: Philippe G Prokocimer, MD Trius Therapeutics
  More Information

No publications provided by Trius Therapeutics, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01170221     History of Changes
Other Study ID Numbers: TR701-112
Study First Received: July 23, 2010
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 September 22, 2014