TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
- Conditions
- Skin and Subcutaneous Tissue Bacterial Infections
- Interventions
- Registration Number
- NCT01421511
- Lead Sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 666
- Patients requiring IV antibiotic therapy and with systemic signs of infection diagnosed with ABSSSI.
- Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections
- Uncomplicated skin infections
- Severe sepsis or septic shock
- ABSSSI solely due to gram-negative pathogens
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Linezolid Linezolid • Linezolid IV followed by Linezolid Tablets TR-701 FA TR-701 FA • TR-701 FA IV followed by TR-701 FA tablets
- Primary Outcome Measures
Name Time Method The Early Clinical Response Rate 48-72 hours Responder: No increase in lesion surface area from baseline.
- Secondary Outcome Measures
Name Time Method Investigator's Assessment of Clinical Success of the Post Therapy Evaluation Visit in Clinically Evaluable-Post Treatment Evaluation Analysis Set. Post-Treatment Evaluation (7-14 days after the End of Therapy) 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.
Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set End of Therapy Day 11 Responder: No increase in lesion surface area from baseline.
Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit Post-Treatment Evaluation (7-14 days after the End of Therapy) 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.
Change From Baseline in Patient-reported Pain, by Study Visit Multiple 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.
Investigator's Assessment of Clinical Response at the 48-72 Hour Visit 48-72 Hours Clinical improvement defined as improvement in overall clinical status.
Investigator's Assessment of Clinical Response at the Day-7 Visit Day 7 Clinical improvement defined as improvement in overall clinical status.
Clinical Response at the End of Therapy Visit Day 11 Responder: No increase in lesion surface area from baseline.
Related Research Topics
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Trial Locations
- Locations (111)
Trius investigator site 287
🇷🇺Barmaul, Russian Federation
Trius investigator 451
🇿🇦Centurion, Gauteng, South Africa
Trius investigator 449
🇿🇦Pretoria, Gauteng, South Africa
Trius investigator 520
🇳🇿Sydenham, Christchurch, New Zealand
Trius investigator 447
🇿🇦Breyten, Mpunalanga, South Africa
Trius investigator site 274
🇪🇸Santander, Spain
Trius investigator site 216
🇵🇱Bydgoszcz, Poland
Trius investigator site 275
🇪🇸Majadahonda, Madrid, Spain
Trius investigator site 276
🇪🇸Madrid, Spain
Trius investigator site 440
🇿🇦Gezina Pretoria, Gauteng, South Africa
Trius investigator site 272
🇪🇸Alcorcon, Madrid, Spain
Trius investigator site 441
🇿🇦Blowmfontein, Free States, South Africa
Trius investigator 521
🇳🇿Otahuhu, Auckland, New Zealand
Trius investigator site 442
🇿🇦Bloemfontein, Free States, South Africa
Trius investigator site 277
🇪🇸Baracaldo, Vizcaya, Spain
Trius investigator site 382
🇲🇽Mexico, DF, Mexico
Trius investigator 444
🇿🇦Worscester, Cape, South Africa
Trius investigator site 445
🇿🇦Benoni, South Africa
Trius investigator site 140
🇺🇸Columbus, Ohio, United States
Trius investigator site 154
🇺🇸Boston, Massachusetts, United States
Trius investigator site 150
🇺🇸Baton Rouge, Louisiana, United States
Trius investigator site 165
🇺🇸Eunice, Louisiana, United States
Trius investigator site 159
🇺🇸Dothan, Alabama, United States
Trius investigator site 103
🇺🇸Chula Vista, California, United States
Trius investigator site 143
🇺🇸Escondido, California, United States
Trius investigator site 106
🇺🇸Long Beach, California, United States
Trius investigator site 105
🇺🇸La Mesa, California, United States
Trius investigator site 142
🇺🇸National City, California, United States
Trius investigator site 157
🇺🇸Long Beach, California, United States
Trius investigator site 170
🇺🇸San Diego, California, United States
Trius investigator site 167
🇺🇸Santa Ana, California, United States
Trius investigator site 168
🇺🇸Stockton, California, United States
Trius investigator site 141
🇺🇸Sylmar, California, United States
Trius investigator site 139
🇺🇸Denver, Colorado, United States
Trius investigator site 166
🇺🇸Edgewater, Florida, United States
Trius investigator site 101
🇺🇸Columbus, Georgia, United States
Trius investigator site 138
🇺🇸Carmel, Indiana, United States
Trius investigator site 144
🇺🇸Owensboro, Kentucky, United States
Trius investigator site 163
🇺🇸Royal Oak, Michigan, United States
Trius investigator site 153
🇺🇸Minneapolis, Minnesota, United States
Trius investigator site 164
🇺🇸Creve Coeur, Missouri, United States
Trius investigator site 162
🇺🇸Lima, Ohio, United States
Trius investigator site 145
🇺🇸Memphis, Tennessee, United States
Trius investigator site 148
🇺🇸Houston, Texas, United States
Trius investigator site 350
🇦🇷La Plata, Buenos Aires, Argentina
Trius investigator site 355
🇦🇷Buenos Aires, Argentina
Trius investigator site 353
🇦🇷Lujan, Buenos Aires, Argentina
Trius investigator site 358
🇦🇷La Plata, Argentina
Trius investigator site 357
🇦🇷Mar del Plata, Argentina
Trius investigator site 359
🇦🇷Paraná, Entre Rios, Argentina
Trius investigator site 356
🇦🇷Rosario, Argentina
Trius investigator 500
🇦🇺Cairns, Queensland, Australia
Trius investigator 501
🇦🇺Herston, Queensland, Australia
Trius investigator 503
🇦🇺Nambour, Queensland, Australia
Trius investigator 502
🇦🇺Woolloongabba, Queensland, Australia
Trius investigator 506
🇦🇺Southport, Queensland, Australia
Trius investigator 504
🇦🇺Woolloongabba, Queensland, Australia
Trius investigator site 362
🇧🇷Belo Horizonte, Brazil
Trius investigator site 361
🇧🇷Belo Horizonte, Brazil
Trius investigator site 364
🇧🇷Campinas, Brazil
Trius investigator site 363
🇧🇷Porto Alegre, Brazil
Trius investigator site 365
🇧🇷Belo Horizonte, Brazil
Trius investigator site 369
🇧🇷Jaú, Brazil
Trius investigator site 360
🇧🇷São Paulo, Brazil
Trius investigator site 206
🇩🇪Quedlinburg, Sachsen-Anhalt, Germany
Trius investigator site 370
🇧🇷Porto Alegre, Brazil
Trius investigator site 208
🇩🇪Dresden, Sachsen, Germany
Trius investigator site 204
🇩🇪Luebeck, Schleswig-Holstein, Germany
Trius investigator site 207
🇩🇪Berlin, Germany
Trius investigator site 205
🇩🇪Hamburg, Germany
Trius investigator site 380
🇲🇽Guadalajara, Mexico
Trius investigator site 169
🇺🇸Smyrna, Tennessee, United States
Trius investigator 505
🇦🇺Richmond, Victoria, Australia
Trius investigator site 136
🇺🇸West Roxbury, Massachusetts, United States
Trius investigator site 352
🇦🇷Cludadela, Buenos Aires, Argentina
Trius investigator site 213
🇵🇱Poznan, Poland
Trius investigator site 215
🇵🇱Szczecin, Poland
Trius investigator site 147
🇺🇸Teaneck, New Jersey, United States
Trius investigator site 351
🇦🇷Cludad Autonoma De Buenos Aires, Argentina
Trius investigator site 137
🇺🇸Newark, Delaware, United States
Trius investigator site 149
🇺🇸Picayune, Mississippi, United States
Trius investigator site 161
🇺🇸Rapid City, South Dakota, United States
Trius investigator site 155
🇺🇸Franklin, Tennessee, United States
Trius investigator site 211
🇵🇱Lodz, Poland
Trius investigator site 212
🇵🇱Warszawa, Poland
Trius investigator site 292
🇷🇺Vsevolozhsk, Leningrad Region, Russian Federation
Trius investigator site 297
🇷🇺Novosibirsk, Russian Federation
Trius investigator site 294
🇷🇺saint-Petersburg, Russian Federation
Trius investigator site 146
🇺🇸Springfield, Massachusetts, United States
Trius investigator 446
🇿🇦Middelburg, Mpumalanga, South Africa
Trius investigator site 354
🇦🇷Buenos Aires, Argentina
Trius investigator site 383
🇲🇽Monterrey, Mexico
Trius investigator site 286
🇷🇺Irkutsk, Russian Federation
Trius investigator site 289
🇷🇺St-Petersburg, Russian Federation
Trius investigator site 160
🇺🇸Las Vegas, Nevada, United States
Trius investigator site 290
🇷🇺Moscow, Russian Federation
Trius investigator site 381
🇲🇽Guadalajara, Mexico
Trius investigator site 214
🇵🇱Lublin, Poland
Trius investigator site 296
🇷🇺Saint-Petersburg, Russian Federation
Trius investigator site 298
🇷🇺Tomsk, Russian Federation
Trius investigator site 273
🇪🇸Mataro, Barcelona, Spain
Trius investigator site 291
🇷🇺Moscow, Russian Federation
Trius investigator site 293
🇷🇺Lipetsk, Russian Federation
Trius investigator site 285
🇷🇺Novosibirsk, Russian Federation
Trius investigator site 288
🇷🇺Moscow, Russian Federation
Trius investigator site 295
🇷🇺Moscow, Russian Federation
Trius investigator 443
🇿🇦Port Elizabeth, Eastern Cape, South Africa
Trius investigator site 366
🇧🇷Curitiba, Brazil
Trius investigator site 367
🇧🇷Curitiba, Brazil
Trius investigator 448
🇿🇦Dundee, Kwa Zulu Natal, South Africa
Trius investigator 450
🇿🇦Pretoria, Gauteng, South Africa