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

Phase 3

Completed

• Conditions: Skin and Subcutaneous Tissue Bacterial Infections
• Interventions: Drug: TR-701 FA; Drug: Linezolid

• Registration Number: NCT01170221
• Lead Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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.

Study Timeline

• Study First Submitted: 2010-07-23
• Study First Submitted QC: 2010-07-26
• Study First Posted: 2010-07-27
• Study Start: 2010-08-15
• Primary Completion: 2011-09-30
• Study Completion: 2011-09-30
• Disposition First Submitted: 2014-04-02
• Disposition First Submitted QC: 2014-04-02
• Disposition First Posted: 2014-04-30
• Results First Submitted: 2014-07-15
• Results First Submitted QC: 2014-08-31
• Results First Posted: 2014-09-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 667

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TR-701 FA	TR-701 FA	TR0-701 FA 200 mg tablets once a day for six days followed by 4 days of placebo
Linezolid	Linezolid	Linezolid 600 mg tablets oral twice a day for 10 days

Primary Outcome Measures

Name	Time	Method
Early Clinical Response Rate	48-72 hours	Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C

Secondary Outcome Measures

Name	Time	Method
Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit	Post-Treatment Evaluation (7-14 days after the End of Therapy)	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.
Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets	EOT Day 11	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.	Day 11	Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C.
Investigator's Assessment of Clinical Response at the 48-72 Hour Visit	48-72 Hour Visit	Clinical improvement was defined as improvement in overall clinical status.
Change From Baseline in Patient-reported Pain, by Study Visit	Multiple	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.
To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set	Post-Treatment Evaluation (7-14 days after the End of Therapy)	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 Day 7 Visit	Day 7	Clinical improvement was defined as improvement in overall clinical status.

Trial Locations

Locations (84)

Trius investigator site 109; 🇺🇸 Dothan, Alabama, United States

Trius Investigator site 130; 🇺🇸 Anaheim, California, United States

Trius investigator site 118; 🇺🇸 Anaheim, California, United States

Trius investigator site 129; 🇺🇸 Buena Park, California, United States

Trius Investigator Site 103; 🇺🇸 Chula Vista, California, United States

Trius Investigator Site 105; 🇺🇸 La Mesa, California, United States

Trius investigator site 126; 🇺🇸 Laguna Beach, California, United States

Trius investigator site 125; 🇺🇸 Norwalk, California, United States

Trius Investigator Site 104; 🇺🇸 Oceanside, California, United States

Trius investigator site 113; 🇺🇸 Oxnard, California, United States

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