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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Trius Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT01421511

First received: August 19, 2011

Last updated: January 30, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 19, 2011

Last Updated Date

January 30, 2013

Start Date ^ICMJE

September 2011

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

determine the noninferiority (NI) in the early clinical response rate [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]

afebrile with cessation of spread of the erythema, edema, and/or induration or reduction in the size (length, width, and area) of erythema, edema, and/or induration from baseline of the primary ABSSSI lesion and nonresponder

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01421511 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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).

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Skin and Subcutaneous Tissue Bacterial Infections

Intervention ^ICMJE

Drug: TR-701 FA for 6 days followed by 4 days of placebo
- 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
Drug: Linezolid for 10 days of treatment
- 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

Study Arm (s)

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

Intervention: Drug: TR-701 FA for 6 days followed by 4 days of placebo
Active Comparator: Linezolid
• Linezolid IV followed by Linezolid Tablets

Intervention: Drug: Linezolid for 10 days of treatment

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

666

Completion Date

January 2013

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Australia, Brazil, Germany, Mexico, New Zealand, Poland, Russian Federation, South Africa, Spain

Administrative Information

NCT Number ^ICMJE

NCT01421511

Other Study ID Numbers ^ICMJE

TR701-113

Has Data Monitoring Committee

Yes

Responsible Party

Trius Therapeutics, Inc.

Study Sponsor ^ICMJE

Trius Therapeutics, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Philippe G Prokocimer, MD

Trius Therapeutics

Information Provided By

Trius Therapeutics, Inc.

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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