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

July 31, 2018 updated by: Trius Therapeutics LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective is to determine the noninferiority (NI) in the early clinical response rate of intravenous (IV) to oral 6 day TR-701 free acid (FA) compared with that of IV to oral 10-day linezolid treatment at 48-72 hours after the first infusion of study drug in the intent-to-treat (ITT) analysis set in patients with acute bacterial skin and skin structure infections (ABSSSI).

Study Type

Interventional

Enrollment (Actual)

666

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Trius investigator site 354
      • Buenos Aires, Argentina
        • Trius investigator site 355
      • Cludad Autonoma De Buenos Aires, Argentina, C1155AHD
        • Trius investigator site 351
      • La Plata, Argentina
        • Trius investigator site 358
      • Mar del Plata, Argentina
        • Trius investigator site 357
      • Paraná, Entre Rios, Argentina
        • Trius investigator site 359
      • Rosario, Argentina
        • Trius investigator site 356
    • Buenos Aires
      • Cludadela, Buenos Aires, Argentina, B1702FWM
        • Trius investigator site 352
      • General Roriquez, Buenos Aires, Argentina, B1748
        • Trius investigator site 354
      • La Plata, Buenos Aires, Argentina, B1900AXI
        • Trius investigator site 350
      • La Plata, Buenos Aires, Argentina
        • Trius investigator site 350
      • Lujan, Buenos Aires, Argentina, B6700AOJ
        • Trius investigator site 353
  • Australia
    • Queensland
      • Cairns, Queensland, Australia, 4870
        • Trius investigator 500
      • Herston, Queensland, Australia, 4029
        • Trius investigator 501
      • Nambour, Queensland, Australia, 4560
        • Trius investigator 503
      • Southport, Queensland, Australia, 4215
        • Trius investigator 506
      • Woolloongabba, Queensland, Australia, 4102
        • Trius investigator 502
      • Woolloongabba, Queensland, Australia, 4102
        • Trius investigator 504
    • Victoria
      • Richmond, Victoria, Australia, 2131
        • Trius investigator 505
  • Brazil
      • Belo Horizonte, Brazil
        • Trius investigator site 361
      • Belo Horizonte, Brazil
        • Trius investigator site 362
      • Belo Horizonte, Brazil
        • Trius investigator site 365
      • Campinas, Brazil
        • Trius investigator site 364
      • Curitiba, Brazil
        • Trius investigator site 366
      • Curitiba, Brazil
        • Trius investigator site 367
      • Jaú, Brazil
        • Trius investigator site 369
      • Porto Alegre, Brazil
        • Trius investigator site 363
      • Porto Alegre, Brazil
        • Trius investigator site 370
      • São Paulo, Brazil
        • Trius investigator site 360
    • MG, Brazil
      • Belo Horizonte, MG, Brazil, Brazil, 30110-934
        • Trius investigator site 362
      • Belo Horizonte, MG, Brazil, Brazil, 30140-062
        • Trius investigator site 361
    • RS, Brazil
      • Porto Alegre, RS, Brazil, Brazil, 90110-270
        • Trius investigator site 363
    • SP, Brazil
      • Campinas, SP, Brazil, Brazil, 13060-904
        • Trius investigator site 364
  • Germany
      • Berlin, Germany, 10249
        • Trius investigator site 207
      • Hamburg, Germany, 20246
        • Trius investigator site 205
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Trius investigator site 208
    • Sachsen-Anhalt
      • Quedlinburg, Sachsen-Anhalt, Germany, 06484
        • Trius investigator site 206
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Germany, 23538
        • Trius investigator site 204
  • Mexico
      • Guadalajara, Mexico
        • Trius investigator site 380
      • Guadalajara, Mexico
        • Trius investigator site 381
      • Mexico, DF, Mexico
        • Trius investigator site 382
      • Monterrey, Mexico
        • Trius investigator site 383
  • New Zealand
    • Auckland
      • Otahuhu, Auckland, New Zealand
        • Trius investigator 521
    • Christchurch
      • Sydenham, Christchurch, New Zealand, 8024
        • Trius investigator 520
  • Poland
      • Bydgoszcz, Poland, 85-094
        • Trius investigator site 216
      • Lodz, Poland, 93-513
        • Trius investigator site 211
      • Lublin, Poland, 20-081
        • Trius investigator site 214
      • Poznan, Poland, 60-631
        • Trius investigator site 213
      • Szczecin, Poland, 70-111
        • Trius investigator site 215
      • Warszawa, Poland, 02-097
        • Trius investigator site 212
  • Russian Federation
      • Barmaul, Russian Federation, 656024
        • Trius investigator site 287
      • Irkutsk, Russian Federation, 664079
        • Trius investigator site 286
      • Lipetsk, Russian Federation, 389035/398005
        • Trius investigator site 293
      • Moscow, Russian Federation, 115093
        • Trius investigator site 295
      • Moscow, Russian Federation, 115280
        • Trius investigator site 290
      • Moscow, Russian Federation, 115280
        • Trius investigator site 291
      • Moscow, Russian Federation, 119435
        • Trius investigator site 288
      • Novosibirsk, Russian Federation, 630008
        • Trius investigator site 297
      • Novosibirsk, Russian Federation, 630051
        • Trius investigator site 285
      • Saint-Petersburg, Russian Federation, 198099
        • Trius investigator site 289
      • Saint-Petersburg, Russian Federation
        • Trius investigator site 296
      • St-Petersburg, Russian Federation, 198099
        • Trius investigator site 289
      • Tomsk, Russian Federation, 634063
        • Trius investigator site 298
      • saint-Petersburg, Russian Federation, 194291
        • Trius investigator site 294
    • Leningrad Region
      • Vsevolozhsk, Leningrad Region, Russian Federation, 188640
        • Trius investigator site 292
  • South Africa
      • Benoni, South Africa, 1501
        • Trius investigator site 445
    • Cape
      • Worscester, Cape, South Africa, 6850
        • Trius investigator 444
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6020
        • Trius investigator 443
    • Free States
      • Bloemfontein, Free States, South Africa, 9317
        • Trius investigator site 442
      • Blowmfontein, Free States, South Africa, 9301
        • Trius investigator site 441
    • Gauteng
      • Centurion, Gauteng, South Africa, 0157
        • Trius investigator 451
      • Gezina Pretoria, Gauteng, South Africa, 0084
        • Trius investigator site 440
      • Pretoria, Gauteng, South Africa, 0083
        • Trius investigator 450
      • Pretoria, Gauteng, South Africa, 0084
        • Trius investigator 449
    • Kwa Zulu Natal
      • Dundee, Kwa Zulu Natal, South Africa, 3000
        • Trius investigator 448
    • Mpumalanga
      • Middelburg, Mpumalanga, South Africa, 1051
        • Trius investigator 446
    • Mpunalanga
      • Breyten, Mpunalanga, South Africa, 2330
        • Trius investigator 447
  • Spain
      • Madrid, Spain, 28046
        • Trius investigator site 276
      • Santander, Spain, 39008
        • Trius investigator site 274
    • Barcelona
      • Mataro, Barcelona, Spain, 08304
        • Trius investigator site 273
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Trius investigator site 272
      • Majadahonda, Madrid, Spain, 28222
        • Trius investigator site 275
    • Vizcaya
      • Baracaldo, Vizcaya, Spain, 48903
        • Trius investigator site 277
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Trius investigator site 159
    • California
      • Chula Vista, California, United States, 91911
        • Trius Investigator Site 103
      • Escondido, California, United States, 92025
        • Trius investigator site 143
      • La Mesa, California, United States, 91942
        • Trius Investigator Site 105
      • Long Beach, California, United States, 90813
        • Trius Investigator Site 106
      • Long Beach, California, United States, 90813
        • Trius investigator site 157
      • National City, California, United States, 91950
        • Trius investigator site 142
      • San Diego, California, United States, 92123
        • Trius investigator site 170
      • Santa Ana, California, United States, 92701
        • Trius investigator site 167
      • Stockton, California, United States, 95204
        • Trius investigator site 168
      • Sylmar, California, United States, 91342
        • Trius investigator site 141
    • Colorado
      • Denver, Colorado, United States, 80218
        • Trius investigator site 139
    • Delaware
      • Newark, Delaware, United States, 19718
        • Trius investigator site 137
    • Florida
      • Edgewater, Florida, United States, 32132
        • Trius investigator site 166
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Trius investigator site 101
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Trius investigator site 138
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Trius investigator site 144
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Trius investigator site 150
      • Eunice, Louisiana, United States, 70535
        • Trius investigator site 165
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Trius investigator site 154
      • Springfield, Massachusetts, United States, 01199
        • Trius investigator site 146
      • West Roxbury, Massachusetts, United States, 02132
        • Trius investigator site 136
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Trius investigator site 163
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Trius investigator site 153
    • Mississippi
      • Picayune, Mississippi, United States, 39466
        • Trius investigator site 149
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Trius investigator site 164
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Trius investigator site 160
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Trius investigator site 147
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Trius investigator site 140
      • Lima, Ohio, United States, 45801
        • Trius investigator site 162
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Trius investigator site 161
    • Tennessee
      • Franklin, Tennessee, United States, 37064
        • Trius investigator site 155
      • Memphis, Tennessee, United States, 38104
        • Trius investigator site 145
      • Smyrna, Tennessee, United States, 37167
        • Trius investigator site 169
    • Texas
      • Houston, Texas, United States, 77030
        • Trius investigator site 148

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients requiring IV antibiotic therapy and with systemic signs of infection diagnosed with 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TR-701 FA
• TR-701 FA IV followed by TR-701 FA tablets
Drug: TR-701 FA
  • 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
Active Comparator: Linezolid
• Linezolid IV followed by Linezolid Tablets
Drug: Linezolid
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Early Clinical Response Rate
Time Frame: 48-72 hours
Responder: No increase in lesion surface area from baseline.
48-72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Response at the End of Therapy Visit
Time Frame: Day 11
Responder: No increase in lesion surface area from baseline.
Day 11
Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set
Time Frame: End of Therapy Day 11
Responder: No increase in lesion surface area from baseline.
End of Therapy Day 11
Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit
Time Frame: Post-Treatment Evaluation (7-14 days after the End of Therapy)
Clinical success defined as resolution/near resolution of disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, and no further antibiotic therapy required for treatment of primary ABSSSI lesion.
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.
Time Frame: Post-Treatment Evaluation (7-14 days after the End of Therapy)
Clinical success defined as resolution/near resolution of disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, no new signs, symptoms or complications attributable to the ABSSSI and no further antibiotic therapy required for treatment of primary ABSSSI lesion.
Post-Treatment Evaluation (7-14 days after the End of Therapy)
Investigator's Assessment of Clinical Response at the 48-72 Hour Visit
Time Frame: 48-72 Hours
Clinical improvement defined as improvement in overall clinical status.
48-72 Hours
Investigator's Assessment of Clinical Response at the Day-7 Visit
Time Frame: Day 7
Clinical improvement defined as improvement in overall clinical status.
Day 7
Change From Baseline in Patient-reported Pain, by Study Visit
Time Frame: 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.
Multiple

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trius Therapeutics LLC

Investigators

  • Study Director: Philippe G Prokocimer, MD, Trius Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2011

Primary Completion (Actual)

January 10, 2013

Study Completion (Actual)

January 10, 2013

Study Registration Dates

First Submitted

August 19, 2011

First Submitted That Met QC Criteria

August 19, 2011

First Posted (Estimate)

August 22, 2011

Study Record Updates

Last Update Posted (Actual)

August 29, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1986-010
  • TR701-113 (Other Identifier: TriusRX Unique ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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