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

Primary Purpose

Skin and Subcutaneous Tissue Bacterial Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TR-701 FA
Linezolid
Sponsored by
Trius Therapeutics LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin and Subcutaneous Tissue Bacterial Infections focused on measuring ABSSSI, Tedizolid Phosphate, TR-701, Acute Bacterial Skin and Skin Structure Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Trius investigator site 159
  • Trius investigator site 103
  • Trius investigator site 143
  • Trius investigator site 105
  • Trius investigator site 106
  • Trius investigator site 157
  • Trius investigator site 142
  • Trius investigator site 170
  • Trius investigator site 167
  • Trius investigator site 168
  • Trius investigator site 141
  • Trius investigator site 139
  • Trius investigator site 137
  • Trius investigator site 166
  • Trius investigator site 101
  • Trius investigator site 138
  • Trius investigator site 144
  • Trius investigator site 150
  • Trius investigator site 165
  • Trius investigator site 154
  • Trius investigator site 146
  • Trius investigator site 136
  • Trius investigator site 163
  • Trius investigator site 153
  • Trius investigator site 149
  • Trius investigator site 164
  • Trius investigator site 160
  • Trius investigator site 147
  • Trius investigator site 140
  • Trius investigator site 162
  • Trius investigator site 161
  • Trius investigator site 155
  • Trius investigator site 145
  • Trius investigator site 169
  • Trius investigator site 148
  • Trius investigator site 352
  • Trius investigator site 354
  • Trius investigator site 350
  • Trius investigator site 350
  • Trius investigator site 353
  • Trius investigator site 354
  • Trius investigator site 355
  • Trius investigator site 351
  • Trius investigator site 358
  • Trius investigator site 357
  • Trius investigator site 359
  • Trius investigator site 356
  • Trius investigator 500
  • Trius investigator 501
  • Trius investigator 503
  • Trius investigator 506
  • Trius investigator 502
  • Trius investigator 504
  • Trius investigator 505
  • Trius investigator site 362
  • Trius investigator site 361
  • Trius investigator site 363
  • Trius investigator site 364
  • Trius investigator site 361
  • Trius investigator site 362
  • Trius investigator site 365
  • Trius investigator site 364
  • Trius investigator site 366
  • Trius investigator site 367
  • Trius investigator site 369
  • Trius investigator site 363
  • Trius investigator site 370
  • Trius investigator site 360
  • Trius investigator site 206
  • Trius investigator site 208
  • Trius investigator site 204
  • Trius investigator site 207
  • Trius investigator site 205
  • Trius investigator site 380
  • Trius investigator site 381
  • Trius investigator site 382
  • Trius investigator site 383
  • Trius investigator 521
  • Trius investigator 520
  • Trius investigator site 216
  • Trius investigator site 211
  • Trius investigator site 214
  • Trius investigator site 213
  • Trius investigator site 215
  • Trius investigator site 212
  • Trius investigator site 292
  • Trius investigator site 287
  • Trius investigator site 286
  • Trius investigator site 293
  • Trius investigator site 295
  • Trius investigator site 290
  • Trius investigator site 291
  • Trius investigator site 288
  • Trius investigator site 297
  • Trius investigator site 285
  • Trius investigator site 294
  • Trius investigator site 289
  • Trius investigator site 296
  • Trius investigator site 289
  • Trius investigator site 298
  • Trius investigator 444
  • Trius investigator 443
  • Trius investigator site 442
  • Trius investigator site 441
  • Trius investigator 451
  • Trius investigator site 440
  • Trius investigator 450
  • Trius investigator 449
  • Trius investigator 448
  • Trius investigator 446
  • Trius investigator 447
  • Trius investigator site 445
  • Trius investigator site 273
  • Trius investigator site 272
  • Trius investigator site 275
  • Trius investigator site 277
  • Trius investigator site 276
  • Trius investigator site 274

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TR-701 FA

Linezolid

Arm Description

• TR-701 FA IV followed by TR-701 FA tablets

• Linezolid IV followed by Linezolid Tablets

Outcomes

Primary Outcome Measures

The Early Clinical Response Rate
Responder: No increase in lesion surface area from baseline.

Secondary Outcome Measures

Clinical Response at the End of Therapy Visit
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
Responder: No increase in lesion surface area from baseline.
Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit
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.
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
Clinical improvement defined as improvement in overall clinical status.
Investigator's Assessment of Clinical Response at the Day-7 Visit
Clinical improvement defined as improvement in overall clinical status.
Change From Baseline in Patient-reported Pain, by Study Visit
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.

Full Information

First Posted
August 19, 2011
Last Updated
July 31, 2018
Sponsor
Trius Therapeutics LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01421511
Brief Title
TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 15, 2011 (Actual)
Primary Completion Date
January 10, 2013 (Actual)
Study Completion Date
January 10, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trius Therapeutics LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin and Subcutaneous Tissue Bacterial Infections
Keywords
ABSSSI, Tedizolid Phosphate, TR-701, Acute Bacterial Skin and Skin Structure Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
666 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TR-701 FA
Arm Type
Experimental
Arm Description
• TR-701 FA IV followed by TR-701 FA tablets
Arm Title
Linezolid
Arm Type
Active Comparator
Arm Description
• Linezolid IV followed by Linezolid Tablets
Intervention Type
Drug
Intervention Name(s)
TR-701 FA
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Linezolid
Intervention Description
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
Primary Outcome Measure Information:
Title
The Early Clinical Response Rate
Description
Responder: No increase in lesion surface area from baseline.
Time Frame
48-72 hours
Secondary Outcome Measure Information:
Title
Clinical Response at the End of Therapy Visit
Description
Responder: No increase in lesion surface area from baseline.
Time Frame
Day 11
Title
Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set
Description
Responder: No increase in lesion surface area from baseline.
Time Frame
End of Therapy Day 11
Title
Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit
Description
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.
Time Frame
Post-Treatment Evaluation (7-14 days after the End of Therapy)
Title
Investigator's Assessment of Clinical Success of the Post Therapy Evaluation Visit in Clinically Evaluable-Post Treatment Evaluation Analysis Set.
Description
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.
Time Frame
Post-Treatment Evaluation (7-14 days after the End of Therapy)
Title
Investigator's Assessment of Clinical Response at the 48-72 Hour Visit
Description
Clinical improvement defined as improvement in overall clinical status.
Time Frame
48-72 Hours
Title
Investigator's Assessment of Clinical Response at the Day-7 Visit
Description
Clinical improvement defined as improvement in overall clinical status.
Time Frame
Day 7
Title
Change From Baseline in Patient-reported Pain, by Study Visit
Description
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.
Time Frame
Multiple

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
28264845
Citation
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.
Results Reference
derived
PubMed Identifier
28003218
Citation
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.
Results Reference
derived
PubMed Identifier
27530088
Citation
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.
Results Reference
derived
PubMed Identifier
25421472
Citation
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.
Results Reference
derived
PubMed Identifier
25246392
Citation
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.
Results Reference
derived
PubMed Identifier
24909499
Citation
Moran 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.
Results Reference
derived

Learn more about this trial

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

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