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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

July 23, 2010
August 31, 2014
August 2010
September 2011   (final data collection date for primary outcome measure)
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
Cessation of spread of skin lesions and absence of fever [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01170221 on ClinicalTrials.gov Archive Site
  • 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.
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 6-Day Oral TR-701 Free Acid and 10-Day Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

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

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.

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
    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
  • Drug: Linezolid
    Oral Linezolid 600 mg twice daily for 10 days
    Other Names:
    • Trade name = Zyvox
    • Generic name = linezolid
  • Experimental: TR-701 FA
    TR0-701 FA 200 mg tablets once a day for six days followed by 4 days of placebo
    Intervention: Drug: TR-701 FA
  • Active Comparator: Linezolid
    Linezolid 600 mg tablets oral twice a day for 10 days
    Intervention: Drug: Linezolid
Prokocimer P, De Anda C, Fang E, Mehra P, Das A. Tedizolid phosphate vs linezolid for treatment of acute bacterial skin and skin structure infections: the ESTABLISH-1 randomized trial. JAMA. 2013 Feb 13;309(6):559-69. doi: 10.1001/jama.2013.241.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
667
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Brazil,   Canada,   Czech Republic,   Germany,   Hungary,   Latvia,   Peru,   Slovakia,   Ukraine
 
NCT01170221
TR701-112
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