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

August 19, 2011
August 31, 2014
September 2011
January 2013   (final data collection date for primary outcome measure)
The Early Clinical Response Rate [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
Responder: No increase in lesion surface area from baseline.
determine the noninferiority (NI) in the early clinical response rate [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01421511 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
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

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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Skin and Subcutaneous Tissue Bacterial Infections
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
666
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
South Africa,   Australia,   New Zealand,   United States,   Germany,   Poland,   Spain,   Russian Federation,   Argentina,   Brazil,   Mexico
 
NCT01421511
TR701-113
Yes
Trius Therapeutics, Inc.
Trius Therapeutics, Inc.
Not Provided
Study Director: Philippe G Prokocimer, MD Trius Therapeutics
Trius Therapeutics, Inc.
August 2014

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