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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
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
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United States of America
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Alabama
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California
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Delaware
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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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


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