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

NCT01170221 | Completed Phase 3 Results DMC

• 2 other identifiers: 1986-009TR701-112
• Study Type: interventional
• Target: 667
• Locations: 11 countries
• Sites: 84

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

Conditions

Skin and Subcutaneous Tissue Bacterial Infections

Keywords

ABSSSI; Tedizolid Phosphate; TR-701; Acute Bacterial Skin and Skin Structure Infections

Outcome Measures

Primary Outcomes (1)

• Early Clinical Response Rate

  Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C

  48-72 hours

Secondary Outcomes (7)

• Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit.

  Day 11

• 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

• Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit

  Post-Treatment Evaluation (7-14 days after the End of Therapy)

• 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)

• Investigator's Assessment of Clinical Response at the 48-72 Hour Visit

  48-72 Hour Visit

Study Arms (2)

TR-701 FA

EXPERIMENTAL

TR0-701 FA 200 mg tablets once a day for six days followed by 4 days of placebo

Drug: TR-701 FA

Linezolid

ACTIVE COMPARATOR

Linezolid 600 mg tablets oral twice a day for 10 days

Drug: Linezolid

Interventions

TR-701 FA DRUG

Oral TR-701 FA 200 mg once daily for six days followed by four days of placebo.

Also known as: Tedizolid Phosphate, TR-700 active moiety

TR-701 FA

Linezolid DRUG

Oral Linezolid 600 mg twice daily for 10 days

Also known as: Trade name = Zyvox, Generic name = linezolid

Linezolid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Uncomplicated skin infections
• Severe sepsis or septic shock
• ABSSSI solely due to gram-negative pathogens

Sponsors & Collaborators

• Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead

Study Sites (84)

Trius investigator site 109

Dothan, Alabama, 36301, United States

Location

Trius Investigator site 130

Anaheim, California, 92801, United States

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Trius investigator site 118

Anaheim, California, 92804, United States

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Trius investigator site 129

Buena Park, California, 90620, United States

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Trius Investigator Site 103

Chula Vista, California, 91911, United States

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Trius Investigator Site 105

La Mesa, California, 91942, United States

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Trius investigator site 126

Laguna Beach, California, 92651, United States

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Trius investigator site 125

Norwalk, California, 90650, United States

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Trius Investigator Site 104

Oceanside, California, 92056, United States

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Trius investigator site 113

Oxnard, California, 93030, United States

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Trius investigator site 123

Pasadena, California, 91105, United States

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Trius Investigator Site 106

Rolling Hills Estates, California, 90274, United States

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Trius investigator site 111

Torrance, California, 90501, United States

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Trius investigator site 132

Torrance, California, 90502, United States

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Trius investigator site 127

Fort Lauderdale, Florida, 33308, United States

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Trius investigator site 135

Hialeah, Florida, 33012, United States

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Trius investigator site 101

Columbus, Georgia, 31904, United States

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Trius Investigator Site 102

Savannah, Georgia, 31406, United States

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Trius Investigator site 116

Chicago, Illinois, 60637, United States

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Trius Investigator Site 108

Springfield, Illinois, 62701, United States

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Trius investigator site 112

Evansville, Indiana, 47714, United States

Location

Trius Investigator Site 107

Detroit, Michigan, 48202, United States

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Trius investigator site 133

Butte, Montana, 59701, United States

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Trius investigator site 128

Las Vegas, Nevada, 89109, United States

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Trius investigator site 115

Somers Point, New Jersey, 08244, United States

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Trius investigator site 114

Toledo, Ohio, 43608, United States

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Trius investigator site 122

Houston, Texas, 77002, United States

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Trius investigator site 120

Houston, Texas, 77005, United States

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Trius investigator site 131

Houston, Texas, 77081, United States

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Trius Investigator site 121

Houston, Texas, 77093, United States

Location

Trius investigator site 307

Avellaneda, Pcia Buenos Aires, B1870CID, Argentina

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Trius investigator site 304

Loma Hermosa, Pcia Buenos Aires, 1657, Argentina

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Trius investigator site 309

Buenos Aires, C1181ACH, Argentina

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Trius investigator site 310

Buenos Aires, C1405CNF, Argentina

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Trius Investigator site 301

Córdoba, cp5000, Argentina

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Trius investigator site 305

Córdoba, X5000AAI, Argentina

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Trius investigator site 300

Córdoba, X5000FAL, Argentina

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Trius investigator site 308

Paraná, E3100BBJ, Argentina

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Trius investigator site 303

Rosario, S2002QEA, Argentina

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Trius investigator site 306

Santa Fe, S3000EOY, Argentina

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Trius investigator site 322

Barro Preto, Belo Horizonte, 30140062, Brazil

Location

Trius investigator site 321

São José do Rio Preto, São Paulo, CEP 15090 000, Brazil

Location

Trius investigator site 323

São Paulo, São Paulo, 04038-705, Brazil

Location

Trius investigator site 320

Belo Horizonte, MG - 30150221, Brazil

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Trius investigator site 170

Winnipeg, Manitoba, R3A 1R9, Canada

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Trius investigator site 172

Hamilton, Ontario, L8N 4A6, Canada

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Trius investigator site 171

Hamilton, Ontario, L8N3Z5, Canada

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Trius investigator site 175

Brownsburg, Quebec, 46112, Canada

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Trius investigator site 173

Chicoutimi, Quebec, G7H 5H6, Canada

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Trius investigator site 174

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Trius investigator site 234

Hradec Králové, 500 05, Czechia

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Trius investigator site 235

Mělník, 276 01, Czechia

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Trius investigator site 233

Ostrava, 708 52, Czechia

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Trius investigator site 236

Pardubice, 532 03, Czechia

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Trius investigator site 231

Prague, 180 81, Czechia

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Trius investigator site 201

Berlin, 10117, Germany

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Trius investigator site 202

Hanau, 63450, Germany

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Trius investigator site 200

Mannheim, 68135, Germany

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Trius investigator site 203

Plauen, 08529, Germany

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Trius investigator site 241

Debrecen, H-4032, Hungary

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Trius investigator site 242

Komló, H-7300, Hungary

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Trius investigator site 240

Szeged, H-6721, Hungary

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Trius investigator site 258

Daugavpils, LV- 5417, Latvia

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Trius investigator site 256

Liepāja, LV -3414, Latvia

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Trius investigator site 257

Rēzekne, LV-4600, Latvia

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Trius investigator site 255

Riga, LV-1002, Latvia

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Trius investigator site 343

Lima Cercado, Lima region, 01, Peru

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Trius investigator site 342

Miraflores, Lima region, 18, Peru

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Trius investigator site 341

San Juan de Miraflores, Lima region, 29, Peru

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Trius investigator site 340

Arequipa, 054, Peru

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Trius investigator site 251

Banská Bystrica, 97517, Slovakia

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Trius investigator site 250

Martin, 036 59, Slovakia

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Trius investigator site 271

Cherkassy, 18009, Ukraine

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Trius investigator site 264

Dnipro, 49000, Ukraine

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Trius investigator site 263

Dnipro, 49600, Ukraine

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Trius investigator site 269

Ivano-Frankivsk, 07618, Ukraine

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Trius investigator site 260

Kharkiv, 61037, Ukraine

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Trius investigator site 261

Kyiv, 03110, Ukraine

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Trius investigator site 268

Lviv, 79000, Ukraine

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Trius investigator site 265

Lviv, 79044, Ukraine

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Trius Investigator site 270

Ternopil, 46000, Ukraine

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Trius investigator site 266

Uzhhorod, 88018, Ukraine

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Trius investigator site 262

Zaporizhzhya, 69032, Ukraine

Location

Trius investigator site 267

Zhytomyr, 10002, Ukraine

Location

Related Publications (7)

• 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.

  PMID: 28264845 DERIVED

• 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.

  PMID: 28003218 DERIVED

• 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.

  PMID: 27530088 DERIVED

• 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.

  PMID: 25421472 DERIVED

• 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.

  PMID: 25246392 DERIVED

• 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.

  PMID: 24450727 DERIVED

• 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.

  PMID: 23403680 DERIVED

MeSH Terms

Interventions

tedizolid phosphate; Linezolid

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Philippe Prokocimer, MD
• Organization: Cubist Pharmaceuticals, Inc.

Philippe.Prokocimer@cubist.com

858-452-0370

Study Officials

• Philippe G Prokocimer, MD

  Trius Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2010
• First Posted: July 27, 2010
• Study Start: August 15, 2010
• Primary Completion: September 30, 2011
• Study Completion: September 30, 2011
• Last Updated: August 29, 2018
• Results First Posted: September 3, 2014

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

CZ (5); US (30); CA (6); BR (4); SL (2); DE (4); AR (10); LA (4); HU (3); UA (12); PE (4)