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: April 2, 2014
Last verified: April 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:
  • 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 6-day oral TR-701 free acid (FA) compared with that of 10-day oral linezolid treatment at 48-72 hours in the Intent-to-Treat (ITT) analysis set in patients with acute bacterial skin and skin structure infections (ABSSSI)


Secondary Outcome Measures:
  • To compare the clinical response of 6-day TR-701 FA and 10-day linezolid treatment at 48-72 hours that is sustained at the End of Therapy (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 Post-Therapy Evaluation (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 TR-701 FA in comparison with that of linezolid [ Time Frame: Multiple Visits ] [ Designated as safety issue: Yes ]
  • To assess the population pharmacokinetic (PK) profile of TR-700 [ Time Frame: Multiple Visits ] [ Designated as safety issue: No ]

Enrollment: 668
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

  Hide Study Locations
Locations
United States, Alabama
Trius investigator site 109
Dothan, Alabama, United States, 36301
United States, California
Trius investigator site 118
Anaheim, California, United States, 92804
Trius Investigator site 130
Anaheim, California, United States, 92801
Trius investigator site 129
Buena Park, California, United States, 90620
Trius Investigator Site 103
Chula Vista, California, United States, 91911
Trius Investigator Site 105
La Mesa, California, United States, 91942
Trius investigator site 126
Laguna Beach, California, United States, 92651
Trius investigator site 125
Norwalk, California, United States, 90650
Trius Investigator Site 104
Oceanside, California, United States, 92056
Trius investigator site 113
Oxnard, California, United States, 93030
Trius investigator site 123
Pasadena, California, United States, 91105
Trius Investigator Site 106
Rolling Hills Estates, California, United States, 90274
Trius investigator site 132
Torrance, California, United States, 90502
Trius investigator site 111
Torrance, California, United States, 90501
United States, Florida
Trius investigator site 127
Ft. Lauderdale, Florida, United States, 33308
Trius investigator site 135
Hialeah, Florida, United States, 33012
United States, Georgia
Trius investigator site 101
Columbus, Georgia, United States, 31904
Trius Investigator Site 102
Savannah, Georgia, United States, 31406
United States, Illinois
Trius Investigator site 116
Chicago, Illinois, United States, 60637
Trius Investigator Site 108
Springfield, Illinois, United States, 62701
United States, Indiana
Trius investigator site 112
Evansville, Indiana, United States, 47714
United States, Michigan
Trius Investigator Site 107
Detroit, Michigan, United States, 48202
United States, Montana
Trius investigator site 133
Butte, Montana, United States, 59701
United States, Nevada
Trius investigator site 128
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Trius investigator site 115
Somers Point, New Jersey, United States, 08244
United States, Ohio
Trius investigator site 114
Toledo, Ohio, United States, 43608
United States, Texas
Trius investigator site 120
Houston, Texas, United States, 77005
Trius Investigator site 121
Houston, Texas, United States, 77093
Trius investigator site 122
Houston, Texas, United States, 77002
Trius investigator site 131
Houston, Texas, United States, 77081
Argentina
Trius investigator site 307
Avellaneda, Pcia Buenos Aires, Argentina, B1870CID
Trius investigator site 304
Loma Hermosa, Pcia Buenos Aires, Argentina, 1657
Trius investigator site 310
Buenos Aires, Argentina, C1405CNF
Trius investigator site 309
Buenos Aires, Argentina, C1181ACH
Trius Investigator site 301
Cordoba, Argentina, cp5000
Trius investigator site 300
Cordoba, Argentina, X5000FAL
Trius investigator site 305
Córdoba, Argentina, X5000AAI
Trius investigator site 308
Parana, Argentina, E3100BBJ
Trius investigator site 303
Rosario, Argentina, S2002QEA
Trius investigator site 306
Santa Fe, Argentina, S3000EOY
Brazil
Trius investigator site 322
Barro Preto, Belo Horizonte, Brazil, 30140062
Trius investigator site 323
Sao Paulo, SP, Brazil, 04038-705
Trius investigator site 321
São José do Rio Preto, SP, Brazil, CEP 15090 000
Trius investigator site 320
Belo Horizonte, Brazil, MG - 30150221
Canada, Manitoba
Trius investigator site 170
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
Trius investigator site 171
Hamilton, Ontario, Canada, L8N3Z5
Trius investigator site 172
Hamilton, Ontario, Canada, L8N 4A6
Canada, Quebec
Trius investigator site 175
Brownsburg, Quebec, Canada, 46112
Trius investigator site 173
Chicoutimi, Quebec, Canada, G7H 5H6
Trius investigator site 174
Sherbrooke, Quebec, Canada, J1H 5N4
Czech Republic
Trius investigator site 234
Hradec Kralove, Czech Republic, 500 05
Trius investigator site 235
Melnik, Czech Republic, 276 01
Trius investigator site 233
Ostrava, Czech Republic, 708 52
Trius investigator site 236
Pardubice, Czech Republic, 532 03
Trius investigator site 231
Prague, Czech Republic, 180 81
Germany
Trius investigator site 201
Berlin, Germany, 10117
Trius investigator site 202
Hanau, Germany, 63450
Trius investigator site 200
Mannheim, Germany, 68135
Trius investigator site 203
Plauen, Germany, 08529
Hungary
Trius investigator site 241
Debrecen, Hungary, H-4032
Trius investigator site 242
Komló, Hungary, H-7300
Trius investigator site 240
Szeged, Hungary, H-6721
Latvia
Trius investigator site 258
Daugavpils, Latvia, LV- 5417
Trius investigator site 256
Liepaja, Latvia, LV -3414
Trius investigator site 257
Rezekne, Latvia, LV-4600
Trius investigator site 255
Riga, Latvia, LV-1002
Peru
Trius investigator site 343
Cercado de Lima, Lima, Peru, 01
Trius investigator site 342
Miraflores, Lima, Peru, 18
Trius investigator site 341
San Juan de Miraflores, Lima, Peru, 29
Trius investigator site 340
Arequipa, Peru, 054
Slovakia
Trius investigator site 251
Banská Bystrica, Slovakia, 97517
Trius investigator site 250
Martin, Slovakia, 036 59
Ukraine
Trius investigator site 271
Cherkassy, Ukraine, 18009
Trius investigator site 263
Dnepropetrovsk, Ukraine, 49600
Trius investigator site 264
Dnepropetrovsk, Ukraine, 49000
Trius investigator site 269
Ivano-Frankivsk, Ukraine, 07618
Trius investigator site 260
Kharkiv, Ukraine, 61037
Trius investigator site 261
Kyiv, Ukraine, 03110
Trius investigator site 268
Lviv, Ukraine, 79000
Trius investigator site 265
Lviv, Ukraine, 79044
Trius Investigator site 270
Ternopil, Ukraine, 46000
Trius investigator site 266
Uzhgorod, Ukraine, 88018
Trius investigator site 262
Zaporizhzhya, Ukraine, 69032
Trius investigator site 267
Zhytomyr, Ukraine, 10002
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
Last Updated: April 2, 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:
Bacterial Infections
Linezolid
Oxazolidinones
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014