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

Last updated: July 31, 2018
Sponsor: Trius Therapeutics LLC
Overall Status: Completed

Phase

3

Condition

Bacterial Infections

Treatment

N/A

Clinical Study ID

NCT01170221
1986-009
TR701-112
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with systemic signs of infection diagnosed with acute bacterial skin and skinstructure infection (ABSSSI)

  • Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections

Exclusion

Exclusion Criteria:

  • Uncomplicated skin infections

  • Severe sepsis or septic shock

  • ABSSSI solely due to gram-negative pathogens

Study Design

Total Participants: 667
Study Start date:
August 15, 2010
Estimated Completion Date:
September 30, 2011

Study 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.

Connect with a study center

  • Trius investigator site 307

    Avellaneda, Pcia Buenos Aires B1870CID
    Argentina

    Site Not Available

  • Trius investigator site 304

    Loma Hermosa, Pcia Buenos Aires 1657
    Argentina

    Site Not Available

  • Trius investigator site 309

    Buenos Aires, C1181ACH
    Argentina

    Site Not Available

  • Trius investigator site 310

    Buenos Aires, C1405CNF
    Argentina

    Site Not Available

  • Trius Investigator site 301

    Cordoba, cp5000
    Argentina

    Site Not Available

  • Trius investigator site 300

    Cordoba, X5000FAL
    Argentina

    Site Not Available

  • Trius investigator site 305

    Córdoba, X5000AAI
    Argentina

    Site Not Available

  • Trius investigator site 305

    Córdoba, X5000AAI
    Argentina

    Site Not Available

  • Trius investigator site 308

    Parana, E3100BBJ
    Argentina

    Site Not Available

  • Trius investigator site 303

    Rosario, S2002QEA
    Argentina

    Site Not Available

  • Trius investigator site 306

    Santa Fe, S3000EOY
    Argentina

    Site Not Available

  • Trius investigator site 322

    Barro Preto, Belo Horizonte 30140062
    Brazil

    Site Not Available

  • Trius investigator site 323

    Sao Paulo, SP 04038-705
    Brazil

    Site Not Available

  • Trius investigator site 321

    São José do Rio Preto, SP CEP 15090 000
    Brazil

    Site Not Available

  • Trius investigator site 321

    São José do Rio Preto, SP CEP 15090 000
    Brazil

    Site Not Available

  • Trius investigator site 320

    Belo Horizonte, MG - 30150221
    Brazil

    Site Not Available

  • Trius investigator site 170

    Winnipeg, Manitoba R3A 1R9
    Canada

    Site Not Available

  • Trius investigator site 171

    Hamilton, Ontario L8N3Z5
    Canada

    Site Not Available

  • Trius investigator site 172

    Hamilton, Ontario L8N 4A6
    Canada

    Site Not Available

  • Trius investigator site 175

    Brownsburg, Quebec 46112
    Canada

    Site Not Available

  • Trius investigator site 173

    Chicoutimi, Quebec G7H 5H6
    Canada

    Site Not Available

  • Trius investigator site 174

    Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

  • Trius investigator site 234

    Hradec Kralove, 500 05
    Czechia

    Site Not Available

  • Trius investigator site 235

    Melnik, 276 01
    Czechia

    Site Not Available

  • Trius investigator site 233

    Ostrava, 708 52
    Czechia

    Site Not Available

  • Trius investigator site 236

    Pardubice, 532 03
    Czechia

    Site Not Available

  • Trius investigator site 231

    Prague, 180 81
    Czechia

    Site Not Available

  • Trius investigator site 201

    Berlin, 10117
    Germany

    Site Not Available

  • Trius investigator site 202

    Hanau, 63450
    Germany

    Site Not Available

  • Trius investigator site 200

    Mannheim, 68135
    Germany

    Site Not Available

  • Trius investigator site 203

    Plauen, 08529
    Germany

    Site Not Available

  • Trius investigator site 241

    Debrecen, H-4032
    Hungary

    Site Not Available

  • Trius investigator site 242

    Komló, H-7300
    Hungary

    Site Not Available

  • Trius investigator site 242

    Komló, H-7300
    Hungary

    Site Not Available

  • Trius investigator site 240

    Szeged, H-6721
    Hungary

    Site Not Available

  • Trius investigator site 258

    Daugavpils, LV- 5417
    Latvia

    Site Not Available

  • Trius investigator site 256

    Liepaja, LV -3414
    Latvia

    Site Not Available

  • Trius investigator site 257

    Rezekne, LV-4600
    Latvia

    Site Not Available

  • Trius investigator site 255

    Riga, LV-1002
    Latvia

    Site Not Available

  • Trius investigator site 343

    Cercado De Lima, Lima 01
    Peru

    Site Not Available

  • Trius investigator site 342

    Miraflores, Lima 18
    Peru

    Site Not Available

  • Trius investigator site 341

    San Juan de Miraflores, Lima 29
    Peru

    Site Not Available

  • Trius investigator site 340

    Arequipa, 054
    Peru

    Site Not Available

  • Trius investigator site 251

    Banská Bystrica, 97517
    Slovakia

    Site Not Available

  • Trius investigator site 251

    Banská Bystrica, 97517
    Slovakia

    Site Not Available

  • Trius investigator site 250

    Martin, 036 59
    Slovakia

    Site Not Available

  • Trius investigator site 271

    Cherkassy, 18009
    Ukraine

    Site Not Available

  • Trius investigator site 263

    Dnepropetrovsk, 49600
    Ukraine

    Site Not Available

  • Trius investigator site 264

    Dnepropetrovsk, 49000
    Ukraine

    Site Not Available

  • Trius investigator site 269

    Ivano-Frankivsk, 07618
    Ukraine

    Site Not Available

  • Trius investigator site 260

    Kharkiv, 61037
    Ukraine

    Site Not Available

  • Trius investigator site 261

    Kyiv, 03110
    Ukraine

    Site Not Available

  • Trius investigator site 265

    Lviv, 79044
    Ukraine

    Site Not Available

  • Trius investigator site 268

    Lviv, 79000
    Ukraine

    Site Not Available

  • Trius Investigator site 270

    Ternopil, 46000
    Ukraine

    Site Not Available

  • Trius investigator site 266

    Uzhgorod, 88018
    Ukraine

    Site Not Available

  • Trius investigator site 262

    Zaporizhzhya, 69032
    Ukraine

    Site Not Available

  • Trius investigator site 267

    Zhytomyr, 10002
    Ukraine

    Site Not Available

  • Trius investigator site 109

    Dothan, Alabama 36301
    United States

    Site Not Available

  • Trius Investigator site 130

    Anaheim, California 92801
    United States

    Site Not Available

  • Trius investigator site 118

    Anaheim, California 92804
    United States

    Site Not Available

  • Trius investigator site 129

    Buena Park, California 90620
    United States

    Site Not Available

  • Trius Investigator Site 103

    Chula Vista, California 91911
    United States

    Site Not Available

  • Trius Investigator Site 105

    La Mesa, California 91942
    United States

    Site Not Available

  • Trius investigator site 126

    Laguna Beach, California 92651
    United States

    Site Not Available

  • Trius investigator site 125

    Norwalk, California 90650
    United States

    Site Not Available

  • Trius Investigator Site 104

    Oceanside, California 92056
    United States

    Site Not Available

  • Trius investigator site 113

    Oxnard, California 93030
    United States

    Site Not Available

  • Trius investigator site 123

    Pasadena, California 91105
    United States

    Site Not Available

  • Trius Investigator Site 106

    Rolling Hills Estates, California 90274
    United States

    Site Not Available

  • Trius investigator site 111

    Torrance, California 90501
    United States

    Site Not Available

  • Trius investigator site 132

    Torrance, California 90502
    United States

    Site Not Available

  • Trius investigator site 127

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Trius investigator site 127

    Ft. Lauderdale, Florida 33308
    United States

    Site Not Available

  • Trius investigator site 135

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Trius investigator site 101

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Trius Investigator Site 102

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Trius Investigator site 116

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Trius Investigator Site 108

    Springfield, Illinois 62701
    United States

    Site Not Available

  • Trius investigator site 112

    Evansville, Indiana 47714
    United States

    Site Not Available

  • Trius Investigator Site 107

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Trius investigator site 133

    Butte, Montana 59701
    United States

    Site Not Available

  • Trius investigator site 128

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Trius investigator site 115

    Somers Point, New Jersey 08244
    United States

    Site Not Available

  • Trius investigator site 114

    Toledo, Ohio 43608
    United States

    Site Not Available

  • Trius Investigator site 121

    Houston, Texas 77093
    United States

    Site Not Available

  • Trius investigator site 120

    Houston, Texas 77005
    United States

    Site Not Available

  • Trius investigator site 122

    Houston, Texas 77002
    United States

    Site Not Available

  • Trius investigator site 131

    Houston, Texas 77081
    United States

    Site Not Available

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