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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
Titles & IDs
Public title
TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
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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
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Secondary ID [1]
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TR701-113
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Secondary ID [2]
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1986-010
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Skin and Subcutaneous Tissue Bacterial Infections
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The Early Clinical Response Rate
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Assessment method [1]
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Responder: No increase in lesion surface area from baseline.
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Timepoint [1]
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48-72 hours
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Secondary outcome [1]
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Clinical Response at the End of Therapy Visit
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Assessment method [1]
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Responder: No increase in lesion surface area from baseline.
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Timepoint [1]
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Day 11
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Secondary outcome [2]
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Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set
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Assessment method [2]
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Responder: No increase in lesion surface area from baseline.
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Timepoint [2]
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End of Therapy Day 11
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Secondary outcome [3]
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Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit
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Assessment method [3]
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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.
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Timepoint [3]
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Post-Treatment Evaluation (7-14 days after the End of Therapy)
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Secondary outcome [4]
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Investigator's Assessment of Clinical Success of the Post Therapy Evaluation Visit in Clinically Evaluable-Post Treatment Evaluation Analysis Set.
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Assessment method [4]
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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.
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Timepoint [4]
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Post-Treatment Evaluation (7-14 days after the End of Therapy)
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Secondary outcome [5]
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Investigator's Assessment of Clinical Response at the 48-72 Hour Visit
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Assessment method [5]
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Clinical improvement defined as improvement in overall clinical status.
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Timepoint [5]
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48-72 Hours
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Secondary outcome [6]
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Investigator's Assessment of Clinical Response at the Day-7 Visit
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Assessment method [6]
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Clinical improvement defined as improvement in overall clinical status.
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Timepoint [6]
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Day 7
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Secondary outcome [7]
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Change From Baseline in Patient-reported Pain, by Study Visit
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Assessment method [7]
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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.
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Timepoint [7]
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Multiple
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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
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Uncomplicated skin infections
* Severe sepsis or septic shock
* ABSSSI solely due to gram-negative pathogens
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/09/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
10/01/2013
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Sample size
Target
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Accrual to date
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Final
666
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Trius investigator 500 - Cairns
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Trius investigator 501 - Herston
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Trius investigator 503 - Nambour
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Trius investigator 506 - Southport
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Trius investigator 502 - Woolloongabba
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Trius investigator 504 - Woolloongabba
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Trius investigator 505 - Richmond
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Recruitment postcode(s) [1]
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4870 - Cairns
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Recruitment postcode(s) [2]
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4029 - Herston
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4560 - Nambour
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4215 - Southport
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4102 - Woolloongabba
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Recruitment postcode(s) [6]
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2131 - Richmond
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Recruitment outside Australia
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Santander
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01421511
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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.
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Public notes
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Contacts
Principal investigator
Name
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Philippe G Prokocimer, MD
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Address
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Trius Therapeutics
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01421511