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

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

Status and phase: Completed; Phase 3

Conditions: Skin and Subcutaneous Tissue Bacterial Infections

Treatments: Drug: Linezolid; Drug: TR-701 FA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01170221

TR701-112 (Other Identifier)

1986-009

Details and patient eligibility

About

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

Full 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.

Enrollment: 667 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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667 participants in 2 patient groups

TR-701 FA

Experimental group

Description:

TR0-701 FA 200 mg tablets once a day for six days followed by 4 days of placebo

Treatment:

Drug: TR-701 FA

Linezolid

Active Comparator group

Description:

Linezolid 600 mg tablets oral twice a day for 10 days

Treatment:

Drug: Linezolid