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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01421511
First received: August 19, 2011
Last updated: August 31, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Skin and Subcutaneous Tissue Bacterial Infections
Drug: TR-701 FA
Drug: Linezolid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Trius Therapeutics, Inc.:

Primary Outcome Measures:
  • The Early Clinical Response Rate [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]
    Responder: No increase in lesion surface area from baseline.


Secondary Outcome Measures:
  • Clinical Response at the End of Therapy Visit [ Time Frame: Day 11 ] [ Designated as safety issue: No ]
    Responder: No increase in lesion surface area from baseline.

  • 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 ] [ Designated as safety issue: No ]
    Responder: No increase in lesion surface area from baseline.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Investigator's Assessment of Clinical Response at the 48-72 Hour Visit [ Time Frame: 48-72 Hours ] [ Designated as safety issue: No ]
    Clinical improvement defined as improvement in overall clinical status.

  • Investigator's Assessment of Clinical Response at the Day-7 Visit [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Clinical improvement defined as improvement in overall clinical status.

  • Change From Baseline in Patient-reported Pain, by Study Visit [ Time Frame: Multiple ] [ Designated as safety issue: No ]
    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.


Enrollment: 666
Study Start Date: September 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421511

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

No publications provided

Responsible Party: Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01421511     History of Changes
Other Study ID Numbers: TR701-113
Study First Received: August 19, 2011
Results First Received: July 15, 2014
Last Updated: August 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Trius Therapeutics, Inc.:
ABSSSI
Tedizolid Phosphate
TR-701
Acute Bacterial Skin and Skin Structure Infections

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacterial Infections
Linezolid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014