Clinical trial NCT01170221: TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skin and Subcutaneous Tissue Bacterial Infections
Keywords: ABSSSI
Tedizolid Phosphate
TR-701
Acute Bacterial Skin and Skin Structure Infections
Lead sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2010-07-27
Enrollment: 667
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Early Clinical Response Rate
timeFrame: 48-72 hours
Secondary outcomes:
measure: Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit.
timeFrame: Day 11
measure: Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets
timeFrame: EOT Day 11
measure: Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit
timeFrame: Post-Treatment Evaluation (7-14 days after the End of Therapy)
measure: To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set
timeFrame: Post-Treatment Evaluation (7-14 days after the End of Therapy)
measure: Investigator's Assessment of Clinical Response at the 48-72 Hour Visit
timeFrame: 48-72 Hour Visit
measure: Investigator's Assessment of Clinical Response at the Day 7 Visit
timeFrame: Day 7
measure: Change From Baseline in Patient-reported Pain, by Study Visit
timeFrame: Multiple
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Trius investigator site 109
state: Alabama
city: Anaheim
country: United States
facility: Trius Investigator site 130
state: California
city: Anaheim
country: United States
facility: Trius investigator site 118
state: California
city: Buena Park
country: United States
facility: Trius investigator site 129
state: California
city: Chula Vista
country: United States
facility: Trius Investigator Site 103
state: California
city: La Mesa
country: United States
facility: Trius Investigator Site 105
state: California
city: Laguna Beach
country: United States
facility: Trius investigator site 126
state: California
city: Norwalk
country: United States
facility: Trius investigator site 125
state: California
city: Oceanside
country: United States
facility: Trius Investigator Site 104
state: California
city: Oxnard
country: United States
facility: Trius investigator site 113
state: California
city: Pasadena
country: United States
facility: Trius investigator site 123
state: California
city: Rolling Hills Estates
country: United States
facility: Trius Investigator Site 106
state: California
city: Torrance
country: United States
facility: Trius investigator site 111
state: California
city: Torrance
country: United States
facility: Trius investigator site 132
state: California
city: Fort Lauderdale
country: United States
facility: Trius investigator site 127
state: Florida
city: Hialeah
country: United States
facility: Trius investigator site 135
state: Florida
city: Columbus
country: United States
facility: Trius investigator site 101
state: Georgia
city: Savannah
country: United States
facility: Trius Investigator Site 102
state: Georgia
city: Chicago
country: United States
facility: Trius Investigator site 116
state: Illinois
city: Springfield
country: United States
facility: Trius Investigator Site 108
state: Illinois
city: Evansville
country: United States
facility: Trius investigator site 112
state: Indiana
city: Detroit
country: United States
facility: Trius Investigator Site 107
state: Michigan
city: Butte
country: United States
facility: Trius investigator site 133
state: Montana
city: Las Vegas
country: United States
facility: Trius investigator site 128
state: Nevada
city: Somers Point
country: United States
facility: Trius investigator site 115
state: New Jersey
city: Toledo
country: United States
facility: Trius investigator site 114
state: Ohio
city: Houston
country: United States
facility: Trius investigator site 122
state: Texas
city: Houston
country: United States
facility: Trius investigator site 120
state: Texas
city: Houston
country: United States
facility: Trius investigator site 131
state: Texas
city: Houston
country: United States
facility: Trius Investigator site 121
state: Texas
city: Avellaneda
country: Argentina
facility: Trius investigator site 307
state: Pcia Buenos Aires
city: Loma Hermosa
country: Argentina
facility: Trius investigator site 304
state: Pcia Buenos Aires
city: Buenos Aires
country: Argentina
facility: Trius investigator site 309
city: Buenos Aires
country: Argentina
facility: Trius investigator site 310
city: Cordoba
country: Argentina
facility: Trius Investigator site 301
city: Cordoba
country: Argentina
facility: Trius investigator site 300
city: Córdoba
country: Argentina
facility: Trius investigator site 305
city: Parana
country: Argentina
facility: Trius investigator site 308
city: Rosario
country: Argentina
facility: Trius investigator site 303
city: Santa Fe
country: Argentina
facility: Trius investigator site 306
city: Barro Preto
country: Brazil
facility: Trius investigator site 322
state: Belo Horizonte
city: Sao Paulo
country: Brazil
facility: Trius investigator site 323
state: SP
city: São José do Rio Preto
country: Brazil
facility: Trius investigator site 321
state: SP
city: Belo Horizonte
country: Brazil
facility: Trius investigator site 320
city: Winnipeg
country: Canada
facility: Trius investigator site 170
state: Manitoba
city: Hamilton
country: Canada
facility: Trius investigator site 172
state: Ontario
city: Hamilton
country: Canada
facility: Trius investigator site 171
state: Ontario
city: Brownsburg
country: Canada
facility: Trius investigator site 175
state: Quebec
city: Chicoutimi
country: Canada
facility: Trius investigator site 173
state: Quebec
city: Sherbrooke
country: Canada
facility: Trius investigator site 174
state: Quebec
city: Hradec Kralove
country: Czechia
facility: Trius investigator site 234
city: Melnik
country: Czechia
facility: Trius investigator site 235
city: Ostrava
country: Czechia
facility: Trius investigator site 233
city: Pardubice
country: Czechia
facility: Trius investigator site 236
city: Prague
country: Czechia
facility: Trius investigator site 231
city: Berlin
country: Germany
facility: Trius investigator site 201
city: Hanau
country: Germany
facility: Trius investigator site 202
city: Mannheim
country: Germany
facility: Trius investigator site 200
city: Plauen
country: Germany
facility: Trius investigator site 203
city: Debrecen
country: Hungary
facility: Trius investigator site 241
city: Komló
country: Hungary
facility: Trius investigator site 242
city: Szeged
country: Hungary
facility: Trius investigator site 240
city: Daugavpils
country: Latvia
facility: Trius investigator site 258
city: Liepaja
country: Latvia
facility: Trius investigator site 256
city: Rezekne
country: Latvia
facility: Trius investigator site 257
city: Riga
country: Latvia
facility: Trius investigator site 255
city: Cercado De Lima
country: Peru
facility: Trius investigator site 343
state: Lima
city: Miraflores
country: Peru
facility: Trius investigator site 342
state: Lima
city: San Juan de Miraflores
country: Peru
facility: Trius investigator site 341
state: Lima
city: Arequipa
country: Peru
facility: Trius investigator site 340
city: Banská Bystrica
country: Slovakia
facility: Trius investigator site 251
city: Martin
country: Slovakia
facility: Trius investigator site 250
city: Cherkassy
country: Ukraine
facility: Trius investigator site 271
city: Dnepropetrovsk
country: Ukraine
facility: Trius investigator site 264
city: Dnepropetrovsk
country: Ukraine
facility: Trius investigator site 263
city: Ivano-Frankivsk
country: Ukraine
facility: Trius investigator site 269
city: Kharkiv
country: Ukraine
facility: Trius investigator site 260
city: Kyiv
country: Ukraine
facility: Trius investigator site 261
city: Lviv
country: Ukraine
facility: Trius investigator site 268
city: Lviv
country: Ukraine
facility: Trius investigator site 265
city: Ternopil
country: Ukraine
facility: Trius Investigator site 270
city: Uzhgorod
country: Ukraine
facility: Trius investigator site 266
city: Zaporizhzhya
country: Ukraine
facility: Trius investigator site 262
city: Zhytomyr
country: Ukraine
facility: Trius investigator site 267
Study officials:
affiliation: Trius Therapeutics
name: Philippe G Prokocimer, MD
role: STUDY_DIRECTOR
References:
citation: Sandison T, De Anda C, Fang E, Das AF, Prokocimer P. Clinical Response of Tedizolid versus Linezolid in Acute Bacterial Skin and Skin Structure Infections by Severity Measure Using a Pooled Analysis from Two Phase 3 Double-Blind Trials. Antimicrob Agents Chemother. 2017 Apr 24;61(5):e02687-16. doi: 10.1128/AAC.02687-16. Print 2017 May.
citation: Nathwani D, Corey R, Das AF, Sandison T, De Anda C, Prokocimer P. Early Clinical Response as a Predictor of Late Treatment Success in Patients With Acute Bacterial Skin and Skin Structure Infections: Retrospective Analysis of 2 Randomized Controlled Trials. Clin Infect Dis. 2017 Jan 15;64(2):214-217. doi: 10.1093/cid/ciw750. Epub 2016 Dec 21.
citation: Powers JH 3rd, Das AF, De Anda C, Prokocimer P. Clinician-reported lesion measurements in skin infection trials: Definitions, reliability, and association with patient-reported pain. Contemp Clin Trials. 2016 Sep;50:265-72. doi: 10.1016/j.cct.2016.08.010. Epub 2016 Aug 13.
citation: Shorr AF, Lodise TP, Corey GR, De Anda C, Fang E, Das AF, Prokocimer P. Analysis of the phase 3 ESTABLISH trials of tedizolid versus linezolid in acute bacterial skin and skin structure infections. Antimicrob Agents Chemother. 2015 Feb;59(2):864-71. doi: 10.1128/AAC.03688-14. Epub 2014 Nov 24.
citation: Lodise TP, Fang E, Minassian SL, Prokocimer PG. Platelet profile in patients with acute bacterial skin and skin structure infections receiving tedizolid or linezolid: findings from the Phase 3 ESTABLISH clinical trials. Antimicrob Agents Chemother. 2014 Dec;58(12):7198-204. doi: 10.1128/AAC.03509-14. Epub 2014 Sep 22.
citation: Bien P, De Anda C, Prokocimer P. Comparison of digital planimetry and ruler technique to measure ABSSSI lesion sizes in the ESTABLISH-1 study. Surg Infect (Larchmt). 2014 Apr;15(2):105-10. doi: 10.1089/sur.2013.070. Epub 2014 Jan 22.
citation: 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.