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

July 31, 2018 updated by: Trius Therapeutics LLC

A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of 6-Day Oral TR-701 Free Acid and 10-Day Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective is to determine the noninferiority in the early clinical response rate of 6 day oral TR-701 FA compared with that of 10-day oral linezolid treatment at the 48-72 Hour Visit in the ITT analysis set in patients with ABSSSI.

Study Type

Interventional

Enrollment (Actual)

667

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, C1181ACH
        • Trius investigator site 309
      • Buenos Aires, Argentina, C1405CNF
        • Trius investigator site 310
      • Cordoba, Argentina, cp5000
        • Trius Investigator site 301
      • Cordoba, Argentina, X5000FAL
        • Trius investigator site 300
      • Córdoba, Argentina, X5000AAI
        • Trius investigator site 305
      • Parana, Argentina, E3100BBJ
        • Trius investigator site 308
      • Rosario, Argentina, S2002QEA
        • Trius investigator site 303
      • Santa Fe, Argentina, S3000EOY
        • Trius investigator site 306
    • Pcia Buenos Aires
      • Avellaneda, Pcia Buenos Aires, Argentina, B1870CID
        • Trius investigator site 307
      • Loma Hermosa, Pcia Buenos Aires, Argentina, 1657
        • Trius investigator site 304
  • Brazil
      • Belo Horizonte, Brazil, MG - 30150221
        • Trius investigator site 320
    • Belo Horizonte
      • Barro Preto, Belo Horizonte, Brazil, 30140062
        • Trius investigator site 322
    • SP
      • Sao Paulo, SP, Brazil, 04038-705
        • Trius investigator site 323
      • São José do Rio Preto, SP, Brazil, CEP 15090 000
        • Trius investigator site 321
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Trius investigator site 170
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Trius investigator site 172
      • Hamilton, Ontario, Canada, L8N3Z5
        • Trius investigator site 171
    • Quebec
      • Brownsburg, Quebec, Canada, 46112
        • Trius investigator site 175
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Trius investigator site 173
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Trius investigator site 174
  • Czechia
      • Hradec Kralove, Czechia, 500 05
        • Trius investigator site 234
      • Melnik, Czechia, 276 01
        • Trius investigator site 235
      • Ostrava, Czechia, 708 52
        • Trius investigator site 233
      • Pardubice, Czechia, 532 03
        • Trius investigator site 236
      • Prague, Czechia, 180 81
        • Trius investigator site 231
  • Germany
      • Berlin, Germany, 10117
        • Trius investigator site 201
      • Hanau, Germany, 63450
        • Trius investigator site 202
      • Mannheim, Germany, 68135
        • Trius investigator site 200
      • Plauen, Germany, 08529
        • Trius investigator site 203
  • Hungary
      • Debrecen, Hungary, H-4032
        • Trius investigator site 241
      • Komló, Hungary, H-7300
        • Trius investigator site 242
      • Szeged, Hungary, H-6721
        • Trius investigator site 240
  • Latvia
      • Daugavpils, Latvia, LV- 5417
        • Trius investigator site 258
      • Liepaja, Latvia, LV -3414
        • Trius investigator site 256
      • Rezekne, Latvia, LV-4600
        • Trius investigator site 257
      • Riga, Latvia, LV-1002
        • Trius investigator site 255
  • Peru
      • Arequipa, Peru, 054
        • Trius investigator site 340
    • Lima
      • Cercado De Lima, Lima, Peru, 01
        • Trius investigator site 343
      • Miraflores, Lima, Peru, 18
        • Trius investigator site 342
      • San Juan de Miraflores, Lima, Peru, 29
        • Trius investigator site 341
  • Slovakia
      • Banská Bystrica, Slovakia, 97517
        • Trius investigator site 251
      • Martin, Slovakia, 036 59
        • Trius investigator site 250
  • Ukraine
      • Cherkassy, Ukraine, 18009
        • Trius investigator site 271
      • Dnepropetrovsk, Ukraine, 49000
        • Trius investigator site 264
      • Dnepropetrovsk, Ukraine, 49600
        • Trius investigator site 263
      • Ivano-Frankivsk, Ukraine, 07618
        • Trius investigator site 269
      • Kharkiv, Ukraine, 61037
        • Trius investigator site 260
      • Kyiv, Ukraine, 03110
        • Trius investigator site 261
      • Lviv, Ukraine, 79000
        • Trius investigator site 268
      • Lviv, Ukraine, 79044
        • Trius investigator site 265
      • Ternopil, Ukraine, 46000
        • Trius Investigator site 270
      • Uzhgorod, Ukraine, 88018
        • Trius investigator site 266
      • Zaporizhzhya, Ukraine, 69032
        • Trius investigator site 262
      • Zhytomyr, Ukraine, 10002
        • Trius investigator site 267
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36301
        • Trius investigator site 109
    • California
      • Anaheim, California, United States, 92801
        • Trius Investigator site 130
      • Anaheim, California, United States, 92804
        • Trius investigator site 118
      • Buena Park, California, United States, 90620
        • Trius investigator site 129
      • Chula Vista, California, United States, 91911
        • Trius Investigator Site 103
      • La Mesa, California, United States, 91942
        • Trius Investigator Site 105
      • Laguna Beach, California, United States, 92651
        • Trius investigator site 126
      • Norwalk, California, United States, 90650
        • Trius investigator site 125
      • Oceanside, California, United States, 92056
        • Trius Investigator Site 104
      • Oxnard, California, United States, 93030
        • Trius investigator site 113
      • Pasadena, California, United States, 91105
        • Trius investigator site 123
      • Rolling Hills Estates, California, United States, 90274
        • Trius Investigator Site 106
      • Torrance, California, United States, 90501
        • Trius investigator site 111
      • Torrance, California, United States, 90502
        • Trius investigator site 132
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Trius investigator site 127
      • Hialeah, Florida, United States, 33012
        • Trius investigator site 135
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Trius investigator site 101
      • Savannah, Georgia, United States, 31406
        • Trius Investigator Site 102
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Trius Investigator site 116
      • Springfield, Illinois, United States, 62701
        • Trius Investigator Site 108
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Trius investigator site 112
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Trius Investigator Site 107
    • Montana
      • Butte, Montana, United States, 59701
        • Trius investigator site 133
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Trius investigator site 128
    • New Jersey
      • Somers Point, New Jersey, United States, 08244
        • Trius investigator site 115
    • Ohio
      • Toledo, Ohio, United States, 43608
        • Trius investigator site 114
    • Texas
      • Houston, Texas, United States, 77002
        • Trius investigator site 122
      • Houston, Texas, United States, 77005
        • Trius investigator site 120
      • Houston, Texas, United States, 77081
        • Trius investigator site 131
      • Houston, Texas, United States, 77093
        • Trius Investigator site 121

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 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

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
TR0-701 FA 200 mg tablets once a day for six days followed by 4 days of placebo
Drug: TR-701 FA
Oral TR-701 FA 200 mg once daily for six days followed by four days of placebo.
Other Names:
  • Tedizolid Phosphate
  • TR-700 active moiety
Active Comparator: Linezolid
Linezolid 600 mg tablets oral twice a day for 10 days
Drug: Linezolid
Oral Linezolid 600 mg twice daily for 10 days
Other Names:
  • Trade name = Zyvox
  • Generic name = linezolid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early Clinical Response Rate
Time Frame: 48-72 hours
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C
48-72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit.
Time Frame: Day 11
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C.
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
Time Frame: EOT Day 11
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C
EOT 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 most disease-specific signs and symptoms, absence/near resolution of systemic signs of infection, if present at baseline, no new signs, symptoms, or complications attributable to the ABSSSIs so no further antibiotic therapy was required for the treatment of the primary lesion.
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
Time Frame: Post-Treatment Evaluation (7-14 days after the End of Therapy)
Clinical success defined as resolution/near resolution of most disease-specific signs and symptoms, absence/near resolution of systemic signs of infection, no new signs, symptoms, or complications attributable to the ABSSSIs so no further antibiotic therapy was required for the treatment of the primary 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 Hour Visit
Clinical improvement was defined as improvement in overall clinical status.
48-72 Hour Visit
Investigator's Assessment of Clinical Response at the Day 7 Visit
Time Frame: Day 7
Clinical improvement was defined as improvement in overall clinical status.
Day 7

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)

August 15, 2010

Primary Completion (Actual)

September 30, 2011

Study Completion (Actual)

September 30, 2011

Study Registration Dates

First Submitted

July 23, 2010

First Submitted That Met QC Criteria

July 26, 2010

First Posted (Estimate)

July 27, 2010

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

  • 1986-009
  • TR701-112 (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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