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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01421511




Registration number
NCT01421511
Ethics application status
Date submitted
19/08/2011
Date registered
22/08/2011
Date last updated
29/08/2018

Titles & IDs
Public title
TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Scientific 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
Secondary ID [1] 0 0
TR701-113
Secondary ID [2] 0 0
1986-010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin and Subcutaneous Tissue Bacterial Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TR-701 FA
Treatment: Drugs - Linezolid

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

Active comparator: Linezolid - • Linezolid IV followed by Linezolid Tablets


Treatment: Drugs: 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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Early Clinical Response Rate
Timepoint [1] 0 0
48-72 hours
Secondary outcome [1] 0 0
Clinical Response at the End of Therapy Visit
Timepoint [1] 0 0
Day 11
Secondary outcome [2] 0 0
Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set
Timepoint [2] 0 0
End of Therapy Day 11
Secondary outcome [3] 0 0
Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit
Timepoint [3] 0 0
Post-Treatment Evaluation (7-14 days after the End of Therapy)
Secondary outcome [4] 0 0
Investigator's Assessment of Clinical Success of the Post Therapy Evaluation Visit in Clinically Evaluable-Post Treatment Evaluation Analysis Set.
Timepoint [4] 0 0
Post-Treatment Evaluation (7-14 days after the End of Therapy)
Secondary outcome [5] 0 0
Investigator's Assessment of Clinical Response at the 48-72 Hour Visit
Timepoint [5] 0 0
48-72 Hours
Secondary outcome [6] 0 0
Investigator's Assessment of Clinical Response at the Day-7 Visit
Timepoint [6] 0 0
Day 7
Secondary outcome [7] 0 0
Change From Baseline in Patient-reported Pain, by Study Visit
Timepoint [7] 0 0
Multiple

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Uncomplicated skin infections
* Severe sepsis or septic shock
* ABSSSI solely due to gram-negative pathogens

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/09/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/01/2013
Sample size
Target
Accrual to date
Final
666
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Trius investigator 500 - Cairns
Recruitment hospital [2] 0 0
Trius investigator 501 - Herston
Recruitment hospital [3] 0 0
Trius investigator 503 - Nambour
Recruitment hospital [4] 0 0
Trius investigator 506 - Southport
Recruitment hospital [5] 0 0
Trius investigator 502 - Woolloongabba
Recruitment hospital [6] 0 0
Trius investigator 504 - Woolloongabba
Recruitment hospital [7] 0 0
Trius investigator 505 - Richmond
Recruitment postcode(s) [1] 0 0
4870 - Cairns
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
4560 - Nambour
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
2131 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
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United States of America
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Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
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United States of America
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Kentucky
Country [9] 0 0
United States of America
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Louisiana
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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United States of America
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Missouri
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Nevada
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United States of America
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New Jersey
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Ohio
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South Dakota
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Tennessee
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United States of America
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Texas
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Argentina
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Buenos Aires
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Argentina
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Cludad Autonoma De Buenos Aires
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Argentina
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La Plata
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Argentina
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Mar del Plata
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Argentina
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Paraná, Entre Rios
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Argentina
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Rosario
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Brazil
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MG, Brazil
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Brazil
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RS, Brazil
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Brazil
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SP, Brazil
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Brazil
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Belo Horizonte
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Brazil
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Campinas
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Brazil
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Curitiba
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Brazil
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Jaú
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Brazil
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Porto Alegre
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Brazil
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São Paulo
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Germany
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Sachsen-Anhalt
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Germany
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Sachsen
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Germany
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Schleswig-Holstein
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Germany
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Berlin
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Germany
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Hamburg
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Mexico
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Guadalajara
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Mexico
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Mexico, DF
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Mexico
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Monterrey
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New Zealand
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Auckland
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New Zealand
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Christchurch
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Poland
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Bydgoszcz
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Poznan
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Poland
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Szczecin
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Poland
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Warszawa
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Russian Federation
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Leningrad Region
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Russian Federation
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Barmaul
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Russian Federation
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Irkutsk
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Russian Federation
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Lipetsk
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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saint-Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
State/province [60] 0 0
St-Petersburg
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Russian Federation
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Tomsk
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South Africa
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Cape
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South Africa
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Eastern Cape
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South Africa
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Free States
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South Africa
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Gauteng
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South Africa
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Kwa Zulu Natal
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South Africa
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Mpumalanga
Country [68] 0 0
South Africa
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Mpunalanga
Country [69] 0 0
South Africa
State/province [69] 0 0
Benoni
Country [70] 0 0
Spain
State/province [70] 0 0
Barcelona
Country [71] 0 0
Spain
State/province [71] 0 0
Madrid
Country [72] 0 0
Spain
State/province [72] 0 0
Vizcaya
Country [73] 0 0
Spain
State/province [73] 0 0
Santander

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01421511
Trial related presentations / publications
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.
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Philippe G Prokocimer, MD
Address 0 0
Trius Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01421511