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)666 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

666

Conditions

Skin and Subcutaneous Tissue Bacterial Infections

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (117)

Trius investigator site 159

Dothan, Alabama, United States

Trius investigator site 103

Chula Vista, California, United States

Trius investigator site 143

Escondido, California, United States

Trius investigator site 105

La Mesa, California, United States

Trius investigator site 106

Long Beach, California, United States

Outcomes

Primary Outcomes

The Early Clinical Response Rate

Responder: No increase in lesion surface area from baseline.

Time frame: 48-72 hours

Secondary Outcomes

Clinical Response at the End of Therapy Visit

Responder: No increase in lesion surface area from baseline.

Time frame: Day 11

Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set

Responder: No increase in lesion surface area from baseline.

Time frame: End of Therapy Day 11

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

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.

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

Investigator's Assessment of Clinical Success of the Post Therapy Evaluation Visit in Clinically Evaluable-Post Treatment Evaluation Analysis Set.

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.

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 defined as improvement in overall clinical status.

Time frame: 48-72 Hours

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

Clinical improvement 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