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: December 4, 2013
Last verified: December 2013

August 19, 2011
December 4, 2013
September 2011
January 2013   (final data collection date for primary outcome measure)
To determine noninferiority (NI) in the early clinical response rate [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
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)
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
  • To compare the programmatic clinical response of IV to oral 6-day TR-701 FA treatment and IV to oral 10 day linezolid treatment at the EOT Visit (Day 11) in the ITT and Clinically Evaluable at EOT (CE EOT) analysis sets [ Time Frame: Day 11 ] [ Designated as safety issue: No ]
  • To compare the Investigator's assessment of clinical success at the PTE Visit (7-14 days after the EOT Visit) in the ITT and Clinically Evaluable at PTE (CE-PTE) analysis sets [ Time Frame: 7-14 days after the EOT Visit ] [ Designated as safety issue: No ]
  • To compare the Investigator's assessment of clinical response at the 48-72 Hour and Day 7 Visits in the ITT analysis set [ Time Frame: 48-72 Hour and Day 7 Visits ] [ Designated as safety issue: No ]
  • To compare patient-reported pain, by study visit [ Time Frame: Multiple Visits ] [ Designated as safety issue: No ]
  • To evaluate the safety profile of IV to oral TR-701 FA in comparison with that of IV to oral linezolid [ Time Frame: Multiple Visits ] [ Designated as safety issue: Yes ]
  • To assess the population PK profile of TR-700 [ Time Frame: Multiple Visits ] [ Designated as safety issue: No ]
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 for 6 days followed by 4 days of placebo
    • 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 for 10 days of treatment
    • 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 for 6 days followed by 4 days of placebo
  • Active Comparator: Linezolid
    • Linezolid IV followed by Linezolid Tablets
    Intervention: Drug: Linezolid for 10 days of treatment
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
United States,   Argentina,   Australia,   Brazil,   Germany,   Mexico,   New Zealand,   Poland,   Russian Federation,   South Africa,   Spain
 
NCT01421511
TR701-113
Yes
Trius Therapeutics, Inc.
Trius Therapeutics, Inc.
Not Provided
Study Director: Philippe G Prokocimer, MD Trius Therapeutics
Trius Therapeutics, Inc.
December 2013

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