TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.
NCT ID: NCT01170221
Last Updated: 2018-08-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
667 participants
INTERVENTIONAL
2010-08-15
2011-09-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TR-701 FA
TR0-701 FA 200 mg tablets once a day for six days followed by 4 days of placebo
TR-701 FA
Oral TR-701 FA 200 mg once daily for six days followed by four days of placebo.
Linezolid
Linezolid 600 mg tablets oral twice a day for 10 days
Linezolid
Oral Linezolid 600 mg twice daily for 10 days
Interventions
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TR-701 FA
Oral TR-701 FA 200 mg once daily for six days followed by four days of placebo.
Linezolid
Oral Linezolid 600 mg twice daily for 10 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections
Exclusion Criteria
* Severe sepsis or septic shock
* ABSSSI solely due to gram-negative pathogens
18 Years
ALL
No
Sponsors
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Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
INDUSTRY
Responsible Party
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Principal Investigators
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Philippe G Prokocimer, MD
Role: STUDY_DIRECTOR
Trius Therapeutics
Locations
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Trius investigator site 109
Dothan, Alabama, United States
Trius Investigator site 130
Anaheim, California, United States
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 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 104
Oceanside, California, United States
Trius investigator site 113
Oxnard, California, United States
Trius investigator site 123
Pasadena, California, United States
Trius Investigator Site 106
Rolling Hills Estates, California, United States
Trius investigator site 111
Torrance, California, United States
Trius investigator site 132
Torrance, California, United States
Trius investigator site 127
Fort Lauderdale, Florida, United States
Trius investigator site 135
Hialeah, Florida, United States
Trius investigator site 101
Columbus, Georgia, United States
Trius Investigator Site 102
Savannah, Georgia, United States
Trius Investigator site 116
Chicago, Illinois, United States
Trius Investigator Site 108
Springfield, Illinois, United States
Trius investigator site 112
Evansville, Indiana, United States
Trius Investigator Site 107
Detroit, Michigan, United States
Trius investigator site 133
Butte, Montana, United States
Trius investigator site 128
Las Vegas, Nevada, United States
Trius investigator site 115
Somers Point, New Jersey, United States
Trius investigator site 114
Toledo, Ohio, United States
Trius investigator site 122
Houston, Texas, United States
Trius investigator site 120
Houston, Texas, United States
Trius investigator site 131
Houston, Texas, United States
Trius Investigator site 121
Houston, Texas, United States
Trius investigator site 307
Avellaneda, Pcia Buenos Aires, Argentina
Trius investigator site 304
Loma Hermosa, Pcia Buenos Aires, Argentina
Trius investigator site 309
Buenos Aires, , Argentina
Trius investigator site 310
Buenos Aires, , Argentina
Trius Investigator site 301
Córdoba, , Argentina
Trius investigator site 305
Córdoba, , Argentina
Trius investigator site 300
Córdoba, , Argentina
Trius investigator site 308
Paraná, , Argentina
Trius investigator site 303
Rosario, , Argentina
Trius investigator site 306
Santa Fe, , Argentina
Trius investigator site 322
Barro Preto, Belo Horizonte, Brazil
Trius investigator site 321
São José do Rio Preto, São Paulo, Brazil
Trius investigator site 323
São Paulo, São Paulo, Brazil
Trius investigator site 320
Belo Horizonte, , Brazil
Trius investigator site 170
Winnipeg, Manitoba, Canada
Trius investigator site 172
Hamilton, Ontario, Canada
Trius investigator site 171
Hamilton, Ontario, Canada
Trius investigator site 175
Brownsburg, Quebec, Canada
Trius investigator site 173
Chicoutimi, Quebec, Canada
Trius investigator site 174
Sherbrooke, Quebec, Canada
Trius investigator site 234
Hradec Králové, , Czechia
Trius investigator site 235
Mělník, , Czechia
Trius investigator site 233
Ostrava, , Czechia
Trius investigator site 236
Pardubice, , Czechia
Trius investigator site 231
Prague, , Czechia
Trius investigator site 201
Berlin, , Germany
Trius investigator site 202
Hanau, , Germany
Trius investigator site 200
Mannheim, , Germany
Trius investigator site 203
Plauen, , Germany
Trius investigator site 241
Debrecen, , Hungary
Trius investigator site 242
Komló, , Hungary
Trius investigator site 240
Szeged, , Hungary
Trius investigator site 258
Daugavpils, , Latvia
Trius investigator site 256
Liepāja, , Latvia
Trius investigator site 257
Rēzekne, , Latvia
Trius investigator site 255
Riga, , Latvia
Trius investigator site 343
Lima Cercado, Lima region, Peru
Trius investigator site 342
Miraflores, Lima region, Peru
Trius investigator site 341
San Juan de Miraflores, Lima region, Peru
Trius investigator site 340
Arequipa, , Peru
Trius investigator site 251
Banská Bystrica, , Slovakia
Trius investigator site 250
Martin, , Slovakia
Trius investigator site 271
Cherkassy, , Ukraine
Trius investigator site 264
Dnipro, , Ukraine
Trius investigator site 263
Dnipro, , Ukraine
Trius investigator site 269
Ivano-Frankivsk, , Ukraine
Trius investigator site 260
Kharkiv, , Ukraine
Trius investigator site 261
Kyiv, , Ukraine
Trius investigator site 268
Lviv, , Ukraine
Trius investigator site 265
Lviv, , Ukraine
Trius Investigator site 270
Ternopil, , Ukraine
Trius investigator site 266
Uzhhorod, , Ukraine
Trius investigator site 262
Zaporizhzhya, , Ukraine
Trius investigator site 267
Zhytomyr, , Ukraine
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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TR701-112
Identifier Type: OTHER
Identifier Source: secondary_id
1986-009
Identifier Type: -
Identifier Source: org_study_id
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