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

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 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

Sites / Locations

  • Trius investigator site 109
  • Trius Investigator site 130
  • Trius investigator site 118
  • Trius investigator site 129
  • Trius Investigator Site 103
  • Trius Investigator Site 105
  • Trius investigator site 126
  • Trius investigator site 125
  • Trius Investigator Site 104
  • Trius investigator site 113
  • Trius investigator site 123
  • Trius Investigator Site 106
  • Trius investigator site 111
  • Trius investigator site 132
  • Trius investigator site 127
  • Trius investigator site 135
  • Trius investigator site 101
  • Trius Investigator Site 102
  • Trius Investigator site 116
  • Trius Investigator Site 108
  • Trius investigator site 112
  • Trius Investigator Site 107
  • Trius investigator site 133
  • Trius investigator site 128
  • Trius investigator site 115
  • Trius investigator site 114
  • Trius investigator site 122
  • Trius investigator site 120
  • Trius investigator site 131
  • Trius Investigator site 121
  • Trius investigator site 307
  • Trius investigator site 304
  • Trius investigator site 309
  • Trius investigator site 310
  • Trius Investigator site 301
  • Trius investigator site 300
  • Trius investigator site 305
  • Trius investigator site 308
  • Trius investigator site 303
  • Trius investigator site 306
  • Trius investigator site 322
  • Trius investigator site 323
  • Trius investigator site 321
  • Trius investigator site 320
  • Trius investigator site 170
  • Trius investigator site 172
  • Trius investigator site 171
  • Trius investigator site 175
  • Trius investigator site 173
  • Trius investigator site 174
  • Trius investigator site 234
  • Trius investigator site 235
  • Trius investigator site 233
  • Trius investigator site 236
  • Trius investigator site 231
  • Trius investigator site 201
  • Trius investigator site 202
  • Trius investigator site 200
  • Trius investigator site 203
  • Trius investigator site 241
  • Trius investigator site 242
  • Trius investigator site 240
  • Trius investigator site 258
  • Trius investigator site 256
  • Trius investigator site 257
  • Trius investigator site 255
  • Trius investigator site 343
  • Trius investigator site 342
  • Trius investigator site 341
  • Trius investigator site 340
  • Trius investigator site 251
  • Trius investigator site 250
  • Trius investigator site 271
  • Trius investigator site 264
  • Trius investigator site 263
  • Trius investigator site 269
  • Trius investigator site 260
  • Trius investigator site 261
  • Trius investigator site 268
  • Trius investigator site 265
  • Trius Investigator site 270
  • Trius investigator site 266
  • Trius investigator site 262
  • Trius investigator site 267

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TR-701 FA

Linezolid

Arm Description

TR0-701 FA 200 mg tablets once a day for six days followed by 4 days of placebo

Linezolid 600 mg tablets oral twice a day for 10 days

Outcomes

Primary Outcome Measures

Early Clinical Response Rate
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C

Secondary Outcome Measures

Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit.
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C.
Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C
Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit
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.
To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set
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.
Investigator's Assessment of Clinical Response at the 48-72 Hour Visit
Clinical improvement was defined as improvement in overall clinical status.
Investigator's Assessment of Clinical Response at the Day 7 Visit
Clinical improvement was 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
July 23, 2010
Last Updated
July 31, 2018
Sponsor
Trius Therapeutics LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01170221
Brief Title
TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.
Acronym
ABSSSI
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 15, 2010 (Actual)
Primary Completion Date
September 30, 2011 (Actual)
Study Completion Date
September 30, 2011 (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 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
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.

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
667 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TR-701 FA
Arm Type
Experimental
Arm Description
TR0-701 FA 200 mg tablets once a day for six days followed by 4 days of placebo
Arm Title
Linezolid
Arm Type
Active Comparator
Arm Description
Linezolid 600 mg tablets oral twice a day for 10 days
Intervention Type
Drug
Intervention Name(s)
TR-701 FA
Other Intervention Name(s)
Tedizolid Phosphate, TR-700 active moiety
Intervention Description
Oral TR-701 FA 200 mg once daily for six days followed by four days of placebo.
Intervention Type
Drug
Intervention Name(s)
Linezolid
Other Intervention Name(s)
Trade name = Zyvox, Generic name = linezolid
Intervention Description
Oral Linezolid 600 mg twice daily for 10 days
Primary Outcome Measure Information:
Title
Early Clinical Response Rate
Description
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C
Time Frame
48-72 hours
Secondary Outcome Measure Information:
Title
Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit.
Description
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C.
Time Frame
Day 11
Title
Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets
Description
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C
Time Frame
EOT Day 11
Title
Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit
Description
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.
Time Frame
Post-Treatment Evaluation (7-14 days after the End of Therapy)
Title
To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set
Description
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.
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 was defined as improvement in overall clinical status.
Time Frame
48-72 Hour Visit
Title
Investigator's Assessment of Clinical Response at the Day 7 Visit
Description
Clinical improvement was 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 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
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 109
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Facility Name
Trius Investigator site 130
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Trius investigator site 118
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Trius investigator site 129
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
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 105
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Trius investigator site 126
City
Laguna Beach
State/Province
California
ZIP/Postal Code
92651
Country
United States
Facility Name
Trius investigator site 125
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Trius Investigator Site 104
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Trius investigator site 113
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Trius investigator site 123
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Trius Investigator Site 106
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Trius investigator site 111
City
Torrance
State/Province
California
ZIP/Postal Code
90501
Country
United States
Facility Name
Trius investigator site 132
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Trius investigator site 127
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Trius investigator site 135
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
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 102
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Trius Investigator site 116
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Trius Investigator Site 108
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Trius investigator site 112
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Trius Investigator Site 107
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Trius investigator site 133
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Trius investigator site 128
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Trius investigator site 115
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
Trius investigator site 114
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Trius investigator site 122
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
Facility Name
Trius investigator site 120
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
Trius investigator site 131
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Trius Investigator site 121
City
Houston
State/Province
Texas
ZIP/Postal Code
77093
Country
United States
Facility Name
Trius investigator site 307
City
Avellaneda
State/Province
Pcia Buenos Aires
ZIP/Postal Code
B1870CID
Country
Argentina
Facility Name
Trius investigator site 304
City
Loma Hermosa
State/Province
Pcia Buenos Aires
ZIP/Postal Code
1657
Country
Argentina
Facility Name
Trius investigator site 309
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Trius investigator site 310
City
Buenos Aires
ZIP/Postal Code
C1405CNF
Country
Argentina
Facility Name
Trius Investigator site 301
City
Cordoba
ZIP/Postal Code
cp5000
Country
Argentina
Facility Name
Trius investigator site 300
City
Cordoba
ZIP/Postal Code
X5000FAL
Country
Argentina
Facility Name
Trius investigator site 305
City
Córdoba
ZIP/Postal Code
X5000AAI
Country
Argentina
Facility Name
Trius investigator site 308
City
Parana
ZIP/Postal Code
E3100BBJ
Country
Argentina
Facility Name
Trius investigator site 303
City
Rosario
ZIP/Postal Code
S2002QEA
Country
Argentina
Facility Name
Trius investigator site 306
City
Santa Fe
ZIP/Postal Code
S3000EOY
Country
Argentina
Facility Name
Trius investigator site 322
City
Barro Preto
State/Province
Belo Horizonte
ZIP/Postal Code
30140062
Country
Brazil
Facility Name
Trius investigator site 323
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04038-705
Country
Brazil
Facility Name
Trius investigator site 321
City
São José do Rio Preto
State/Province
SP
ZIP/Postal Code
CEP 15090 000
Country
Brazil
Facility Name
Trius investigator site 320
City
Belo Horizonte
ZIP/Postal Code
MG - 30150221
Country
Brazil
Facility Name
Trius investigator site 170
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Trius investigator site 172
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Trius investigator site 171
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3Z5
Country
Canada
Facility Name
Trius investigator site 175
City
Brownsburg
State/Province
Quebec
ZIP/Postal Code
46112
Country
Canada
Facility Name
Trius investigator site 173
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
Facility Name
Trius investigator site 174
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Trius investigator site 234
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Trius investigator site 235
City
Melnik
ZIP/Postal Code
276 01
Country
Czechia
Facility Name
Trius investigator site 233
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Trius investigator site 236
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
Trius investigator site 231
City
Prague
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Trius investigator site 201
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Trius investigator site 202
City
Hanau
ZIP/Postal Code
63450
Country
Germany
Facility Name
Trius investigator site 200
City
Mannheim
ZIP/Postal Code
68135
Country
Germany
Facility Name
Trius investigator site 203
City
Plauen
ZIP/Postal Code
08529
Country
Germany
Facility Name
Trius investigator site 241
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Facility Name
Trius investigator site 242
City
Komló
ZIP/Postal Code
H-7300
Country
Hungary
Facility Name
Trius investigator site 240
City
Szeged
ZIP/Postal Code
H-6721
Country
Hungary
Facility Name
Trius investigator site 258
City
Daugavpils
ZIP/Postal Code
LV- 5417
Country
Latvia
Facility Name
Trius investigator site 256
City
Liepaja
ZIP/Postal Code
LV -3414
Country
Latvia
Facility Name
Trius investigator site 257
City
Rezekne
ZIP/Postal Code
LV-4600
Country
Latvia
Facility Name
Trius investigator site 255
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Trius investigator site 343
City
Cercado De Lima
State/Province
Lima
ZIP/Postal Code
01
Country
Peru
Facility Name
Trius investigator site 342
City
Miraflores
State/Province
Lima
ZIP/Postal Code
18
Country
Peru
Facility Name
Trius investigator site 341
City
San Juan de Miraflores
State/Province
Lima
ZIP/Postal Code
29
Country
Peru
Facility Name
Trius investigator site 340
City
Arequipa
ZIP/Postal Code
054
Country
Peru
Facility Name
Trius investigator site 251
City
Banská Bystrica
ZIP/Postal Code
97517
Country
Slovakia
Facility Name
Trius investigator site 250
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Facility Name
Trius investigator site 271
City
Cherkassy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Trius investigator site 264
City
Dnepropetrovsk
ZIP/Postal Code
49000
Country
Ukraine
Facility Name
Trius investigator site 263
City
Dnepropetrovsk
ZIP/Postal Code
49600
Country
Ukraine
Facility Name
Trius investigator site 269
City
Ivano-Frankivsk
ZIP/Postal Code
07618
Country
Ukraine
Facility Name
Trius investigator site 260
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Trius investigator site 261
City
Kyiv
ZIP/Postal Code
03110
Country
Ukraine
Facility Name
Trius investigator site 268
City
Lviv
ZIP/Postal Code
79000
Country
Ukraine
Facility Name
Trius investigator site 265
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
Trius Investigator site 270
City
Ternopil
ZIP/Postal Code
46000
Country
Ukraine
Facility Name
Trius investigator site 266
City
Uzhgorod
ZIP/Postal Code
88018
Country
Ukraine
Facility Name
Trius investigator site 262
City
Zaporizhzhya
ZIP/Postal Code
69032
Country
Ukraine
Facility Name
Trius investigator site 267
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine

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
24450727
Citation
Bien P, De Anda C, Prokocimer P. Comparison of digital planimetry and ruler technique to measure ABSSSI lesion sizes in the ESTABLISH-1 study. Surg Infect (Larchmt). 2014 Apr;15(2):105-10. doi: 10.1089/sur.2013.070. Epub 2014 Jan 22.
Results Reference
derived
PubMed Identifier
23403680
Citation
Prokocimer P, De Anda C, Fang E, Mehra P, Das A. Tedizolid phosphate vs linezolid for treatment of acute bacterial skin and skin structure infections: the ESTABLISH-1 randomized trial. JAMA. 2013 Feb 13;309(6):559-69. doi: 10.1001/jama.2013.241.
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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