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

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)667 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

667

Conditions

Skin and Subcutaneous Tissue Bacterial Infections

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Early Clinical Response Rate

Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C

Time frame: 48-72 hours

Secondary Outcomes

Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit.

Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C.

Time frame: Day 11

Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets

Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C

Time frame: EOT Day 11

Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit

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.

Time frame: Post-Treatment Evaluation (7-14 days after the End of Therapy)

To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set

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.

Time frame: Post-Treatment Evaluation (7-14 days after the End of Therapy)

Investigator's Assessment of Clinical Response at the 48-72 Hour Visit

Clinical improvement was defined as improvement in overall clinical status.

Time frame: 48-72 Hour Visit

Investigator's Assessment of Clinical Response at the Day 7 Visit

Clinical improvement was defined as improvement in overall clinical status.

Time frame: Day 7

Change From Baseline in Patient-reported Pain, by Study Visit

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.

Time frame: Multiple