TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of IV to Oral 6-Day TR-701 Free Acid and IV to Oral 10-Day Linezolid for the Treatment of ABSSSI
2 other identifiers
interventional
666
11 countries
117
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2011
Shorter than P25 for phase_3
117 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2011
CompletedFirst Posted
Study publicly available on registry
August 22, 2011
CompletedStudy Start
First participant enrolled
September 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2013
CompletedResults Posted
Study results publicly available
September 8, 2014
CompletedAugust 29, 2018
July 1, 2018
1.3 years
August 19, 2011
July 15, 2014
July 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Early Clinical Response Rate
Responder: No increase in lesion surface area from baseline.
48-72 hours
Secondary Outcomes (7)
Clinical Response at the End of Therapy Visit
Day 11
Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set
End of Therapy 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)
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)
Investigator's Assessment of Clinical Response at the 48-72 Hour Visit
48-72 Hours
- +2 more secondary outcomes
Study Arms (2)
TR-701 FA
EXPERIMENTAL• TR-701 FA IV followed by TR-701 FA tablets
Linezolid
ACTIVE COMPARATOR• Linezolid IV followed by Linezolid Tablets
Interventions
* TR-701 FA 200 mg once daily in 250 mL sterile saline for injection as a 60 minute IV infusion * TR-701 FA Tablets, 200 mg, orally once daily
* Linezolid 600 mg IV Injection twice daily in 300 mL sterile saline for injection as a 60 minute IV infusion * Linezolid Tablets, 600 mg, orally every 12 hours
Eligibility Criteria
You may qualify if:
- Patients requiring IV antibiotic therapy and with systemic signs of infection diagnosed with 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (117)
Trius investigator site 159
Dothan, Alabama, 36305, United States
Trius investigator site 103
Chula Vista, California, 91911, United States
Trius investigator site 143
Escondido, California, 92025, United States
Trius investigator site 105
La Mesa, California, 91942, United States
Trius investigator site 106
Long Beach, California, 90813, United States
Trius investigator site 157
Long Beach, California, 90813, United States
Trius investigator site 142
National City, California, 91950, United States
Trius investigator site 170
San Diego, California, 92123, United States
Trius investigator site 167
Santa Ana, California, 92701, United States
Trius investigator site 168
Stockton, California, 95204, United States
Trius investigator site 141
Sylmar, California, 91342, United States
Trius investigator site 139
Denver, Colorado, 80218, United States
Trius investigator site 137
Newark, Delaware, 19718, United States
Trius investigator site 166
Edgewater, Florida, 32132, United States
Trius investigator site 101
Columbus, Georgia, 31904, United States
Trius investigator site 138
Carmel, Indiana, 46032, United States
Trius investigator site 144
Owensboro, Kentucky, 42303, United States
Trius investigator site 150
Baton Rouge, Louisiana, 70809, United States
Trius investigator site 165
Eunice, Louisiana, 70535, United States
Trius investigator site 154
Boston, Massachusetts, 02115, United States
Trius investigator site 146
Springfield, Massachusetts, 01199, United States
Trius investigator site 136
West Roxbury, Massachusetts, 02132, United States
Trius investigator site 163
Royal Oak, Michigan, 48073, United States
Trius investigator site 153
Minneapolis, Minnesota, 55415, United States
Trius investigator site 149
Picayune, Mississippi, 39466, United States
Trius investigator site 164
Creve Coeur, Missouri, 63141, United States
Trius investigator site 160
Las Vegas, Nevada, 89169, United States
Trius investigator site 147
Teaneck, New Jersey, 07666, United States
Trius investigator site 140
Columbus, Ohio, 43215, United States
Trius investigator site 162
Lima, Ohio, 45801, United States
Trius investigator site 161
Rapid City, South Dakota, 57702, United States
Trius investigator site 155
Franklin, Tennessee, 37064, United States
Trius investigator site 145
Memphis, Tennessee, 38104, United States
Trius investigator site 169
Smyrna, Tennessee, 37167, United States
Trius investigator site 148
Houston, Texas, 77030, United States
Trius investigator site 352
Cludadela, Buenos Aires, B1702FWM, Argentina
Trius investigator site 354
General Roriquez, Buenos Aires, B1748, Argentina
Trius investigator site 350
La Plata, Buenos Aires, B1900AXI, Argentina
Trius investigator site 350
La Plata, Buenos Aires, Argentina
Trius investigator site 353
Luján, Buenos Aires, B6700AOJ, Argentina
Trius investigator site 354
Buenos Aires, Argentina
Trius investigator site 355
Buenos Aires, Argentina
Trius investigator site 351
Cludad Autonoma de Buenos Aires, C1155AHD, 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, 4870, Australia
Trius investigator 501
Herston, Queensland, 4029, Australia
Trius investigator 503
Nambour, Queensland, 4560, Australia
Trius investigator 506
Southport, Queensland, 4215, Australia
Trius investigator 502
Woolloongabba, Queensland, 4102, Australia
Trius investigator 504
Woolloongabba, Queensland, 4102, Australia
Trius investigator 505
Richmond, Victoria, 2131, Australia
Trius investigator site 362
Belo Horizonte, MG, Brazil, 30110-934, Brazil
Trius investigator site 361
Belo Horizonte, MG, Brazil, 30140-062, Brazil
Trius investigator site 363
Porto Alegre, RS, Brazil, 90110-270, Brazil
Trius investigator site 364
Campinas, SP, Brazil, 13060-904, Brazil
Trius investigator site 361
Belo Horizonte, Brazil
Trius investigator site 362
Belo Horizonte, Brazil
Trius investigator site 365
Belo Horizonte, Brazil
Trius investigator site 364
Campinas, Brazil
Trius investigator site 366
Curitiba, Brazil
Trius investigator site 367
Curitiba, Brazil
Trius investigator site 369
Jaú, Brazil
Trius investigator site 363
Porto Alegre, Brazil
Trius investigator site 370
Porto Alegre, Brazil
Trius investigator site 360
São Paulo, Brazil
Trius investigator site 208
Dresden, Saxony, 01307, Germany
Trius investigator site 206
Quedlinburg, Saxony-Anhalt, 06484, Germany
Trius investigator site 204
Lübeck, Schleswig-Holstein, 23538, Germany
Trius investigator site 207
Berlin, 10249, Germany
Trius investigator site 205
Hamburg, 20246, Germany
Trius investigator site 380
Guadalajara, Mexico
Trius investigator site 381
Guadalajara, Mexico
Trius investigator site 382
Mexico City, Mexico
Trius investigator site 383
Monterrey, Mexico
Trius investigator 521
Otahuhu, Auckland, New Zealand
Trius investigator 520
Sydenham, Christchurch, 8024, New Zealand
Trius investigator site 216
Bydgoszcz, 85-094, Poland
Trius investigator site 211
Lodz, 93-513, Poland
Trius investigator site 214
Lublin, 20-081, Poland
Trius investigator site 213
Poznan, 60-631, Poland
Trius investigator site 215
Szczecin, 70-111, Poland
Trius investigator site 212
Warsaw, 02-097, Poland
Trius investigator site 292
Vsevolozhsk, Leningradskaya Oblast', 188640, Russia
Trius investigator site 287
Barmaul, 656024, Russia
Trius investigator site 286
Irkutsk, 664079, Russia
Trius investigator site 293
Lipetsk, 389035/398005, Russia
Trius investigator site 295
Moscow, 115093, Russia
Trius investigator site 290
Moscow, 115280, Russia
Trius investigator site 291
Moscow, 115280, Russia
Trius investigator site 288
Moscow, 119435, Russia
Trius investigator site 297
Novosibirsk, 630008, Russia
Trius investigator site 285
Novosibirsk, 630051, Russia
Trius investigator site 294
Saint Petersburg, 194291, Russia
Trius investigator site 289
Saint Petersburg, 198099, Russia
Trius investigator site 296
Saint Petersburg, Russia
Trius investigator site 298
Tomsk, 634063, Russia
Trius investigator 444
Worscester, Cape, 6850, South Africa
Trius investigator 443
Port Elizabeth, Eastern Cape, 6020, South Africa
Trius investigator site 442
Bloemfontein, Free States, 9317, South Africa
Trius investigator site 441
Blowmfontein, Free States, 9301, South Africa
Trius investigator 451
Centurion, Gauteng, 0157, South Africa
Trius investigator site 440
Gezina Pretoria, Gauteng, 0084, South Africa
Trius investigator 450
Pretoria, Gauteng, 0083, South Africa
Trius investigator 449
Pretoria, Gauteng, 0084, South Africa
Trius investigator 448
Dundee, KwaZulu-Natal, 3000, South Africa
Trius investigator 446
Middelburg, Mpumalanga, 1051, South Africa
Trius investigator 447
Breyten, Mpunalanga, 2330, South Africa
Trius investigator site 445
Benoni, 1501, South Africa
Trius investigator site 273
Mataró, Barcelona, 08304, Spain
Trius investigator site 272
Alcorcón, Madrid, 28922, Spain
Trius investigator site 275
Majadahonda, Madrid, 28222, Spain
Trius investigator site 277
Barakaldo, Vizcaya, 48903, Spain
Trius investigator site 276
Madrid, 28046, Spain
Trius investigator site 274
Santander, 39008, Spain
Related Publications (6)
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: 28264845DERIVEDNathwani 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: 28003218DERIVEDPowers 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: 27530088DERIVEDShorr 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: 25421472DERIVEDLodise 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: 25246392DERIVEDMoran GJ, Fang E, Corey GR, Das AF, De Anda C, Prokocimer P. Tedizolid for 6 days versus linezolid for 10 days for acute bacterial skin and skin-structure infections (ESTABLISH-2): a randomised, double-blind, phase 3, non-inferiority trial. Lancet Infect Dis. 2014 Aug;14(8):696-705. doi: 10.1016/S1473-3099(14)70737-6. Epub 2014 Jun 5.
PMID: 24909499DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Analyses for this study were conducted using 2 statistical plans, 1 for the US FDA and 1 for the EMA, to address differing guidance on the development of antibacterials. These differences are reflected in the EudraCT and clinicaltrials.gov records.
Results Point of Contact
- Title
- Philippe Prokocimer, MD
- Organization
- Cubist Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Philippe G Prokocimer, MD
Trius Therapeutics
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
August 19, 2011
First Posted
August 22, 2011
Study Start
September 15, 2011
Primary Completion
January 10, 2013
Study Completion
January 10, 2013
Last Updated
August 29, 2018
Results First Posted
September 8, 2014
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will share
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf