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
- NCT01170221
- 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 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 667
- 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
- 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 TR-701 FA TR-701 FA TR0-701 FA 200 mg tablets once a day for six days followed by 4 days of placebo Linezolid Linezolid Linezolid 600 mg tablets oral twice a day for 10 days
- Primary Outcome Measures
Name Time Method Early Clinical Response Rate 48-72 hours Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C
- Secondary Outcome Measures
Name Time Method 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 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.
Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets EOT Day 11 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. Day 11 Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C.
Investigator's Assessment of Clinical Response at the 48-72 Hour Visit 48-72 Hour Visit Clinical improvement was defined as improvement in overall clinical status.
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.
To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the 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 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 Day 7 Visit Day 7 Clinical improvement was defined as improvement in overall clinical status.
Trial Locations
- Locations (84)
Trius investigator site 135
🇺🇸Hialeah, Florida, United States
Trius investigator site 133
🇺🇸Butte, Montana, United States
Trius investigator site 120
🇺🇸Houston, Texas, United States
Trius investigator site 128
🇺🇸Las Vegas, Nevada, United States
Trius investigator site 242
🇭🇺Komló, Hungary
Trius investigator site 256
🇱🇻Liepaja, Latvia
Trius investigator site 257
🇱🇻Rezekne, Latvia
Trius investigator site 255
🇱🇻Riga, Latvia
Trius investigator site 251
🇸🇰Banská Bystrica, Slovakia
Trius investigator site 341
🇵🇪San Juan de Miraflores, Lima, Peru
Trius investigator site 265
🇺🇦Lviv, Ukraine
Trius investigator site 264
🇺🇦Dnepropetrovsk, Ukraine
Trius investigator site 118
🇺🇸Anaheim, California, United States
Trius investigator site 129
🇺🇸Buena Park, California, United States
Trius Investigator Site 103
🇺🇸Chula Vista, California, United States
Trius investigator site 109
🇺🇸Dothan, Alabama, United States
Trius Investigator site 130
🇺🇸Anaheim, California, United States
Trius investigator site 123
🇺🇸Pasadena, California, United States
Trius investigator site 234
🇨🇿Hradec Kralove, Czechia
Trius investigator site 235
🇨🇿Melnik, Czechia
Trius investigator site 322
🇧🇷Barro Preto, Belo Horizonte, Brazil
Trius investigator site 323
🇧🇷Sao Paulo, SP, Brazil
Trius investigator site 111
🇺🇸Torrance, California, United States
Trius investigator site 309
🇦🇷Buenos Aires, Argentina
Trius investigator site 310
🇦🇷Buenos Aires, Argentina
Trius Investigator Site 105
🇺🇸La Mesa, California, United States
Trius investigator site 126
🇺🇸Laguna Beach, California, United States
Trius investigator site 125
🇺🇸Norwalk, California, United States
Trius investigator site 113
🇺🇸Oxnard, California, United States
Trius investigator site 127
🇺🇸Fort Lauderdale, Florida, United States
Trius investigator site 101
🇺🇸Columbus, Georgia, United States
Trius Investigator Site 108
🇺🇸Springfield, Illinois, United States
Trius investigator site 304
🇦🇷Loma Hermosa, Pcia Buenos Aires, Argentina
Trius Investigator site 301
🇦🇷Cordoba, Argentina
Trius Investigator site 121
🇺🇸Houston, Texas, United States
Trius investigator site 300
🇦🇷Cordoba, Argentina
Trius investigator site 308
🇦🇷Parana, Argentina
Trius investigator site 306
🇦🇷Santa Fe, Argentina
Trius investigator site 170
🇨🇦Winnipeg, Manitoba, Canada
Trius investigator site 305
🇦🇷Córdoba, Argentina
Trius investigator site 321
🇧🇷São José do Rio Preto, SP, Brazil
Trius investigator site 320
🇧🇷Belo Horizonte, Brazil
Trius investigator site 173
🇨🇦Chicoutimi, Quebec, Canada
Trius investigator site 303
🇦🇷Rosario, Argentina
Trius investigator site 231
🇨🇿Prague, Czechia
Trius investigator site 172
🇨🇦Hamilton, Ontario, Canada
Trius investigator site 233
🇨🇿Ostrava, Czechia
Trius investigator site 241
🇭🇺Debrecen, Hungary
Trius investigator site 201
🇩🇪Berlin, Germany
Trius investigator site 202
🇩🇪Hanau, Germany
Trius investigator site 236
🇨🇿Pardubice, Czechia
Trius investigator site 203
🇩🇪Plauen, Germany
Trius investigator site 240
🇭🇺Szeged, Hungary
Trius investigator site 342
🇵🇪Miraflores, Lima, Peru
Trius investigator site 268
🇺🇦Lviv, Ukraine
Trius Investigator site 270
🇺🇦Ternopil, Ukraine
Trius investigator site 266
🇺🇦Uzhgorod, Ukraine
Trius investigator site 343
🇵🇪Cercado De Lima, Lima, Peru
Trius investigator site 269
🇺🇦Ivano-Frankivsk, Ukraine
Trius investigator site 260
🇺🇦Kharkiv, Ukraine
Trius investigator site 261
🇺🇦Kyiv, Ukraine
Trius investigator site 267
🇺🇦Zhytomyr, Ukraine
Trius investigator site 171
🇨🇦Hamilton, Ontario, Canada
Trius investigator site 200
🇩🇪Mannheim, Germany
Trius investigator site 132
🇺🇸Torrance, California, United States
Trius Investigator Site 102
🇺🇸Savannah, Georgia, United States
Trius Investigator Site 107
🇺🇸Detroit, Michigan, United States
Trius investigator site 122
🇺🇸Houston, Texas, United States
Trius Investigator site 116
🇺🇸Chicago, Illinois, United States
Trius Investigator Site 104
🇺🇸Oceanside, California, United States
Trius investigator site 307
🇦🇷Avellaneda, Pcia Buenos Aires, Argentina
Trius investigator site 115
🇺🇸Somers Point, New Jersey, United States
Trius investigator site 112
🇺🇸Evansville, Indiana, United States
Trius investigator site 131
🇺🇸Houston, Texas, United States
Trius investigator site 175
🇨🇦Brownsburg, Quebec, Canada
Trius investigator site 258
🇱🇻Daugavpils, Latvia
Trius investigator site 340
🇵🇪Arequipa, Peru
Trius investigator site 271
🇺🇦Cherkassy, Ukraine
Trius investigator site 263
🇺🇦Dnepropetrovsk, Ukraine
Trius investigator site 174
🇨🇦Sherbrooke, Quebec, Canada
Trius investigator site 250
🇸🇰Martin, Slovakia
Trius investigator site 262
🇺🇦Zaporizhzhya, Ukraine
Trius investigator site 114
🇺🇸Toledo, Ohio, United States
Trius Investigator Site 106
🇺🇸Rolling Hills Estates, California, United States