MRX-I Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection

MicuRx120 enrolled

Overview

The purpose of this study is to determine whether MRX-I is as safe and effective as Linezolid in the treatment of adult patients with acute bacterial skin and skin structure infections

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Bacterial Infections

Interventions

MRX-IDRUG

Oral MRX-I 800mg given twice a day for 10 days

LinezolidDRUG

Oral linezolid 600mg given twice a day for 10 days

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 * Prior systemic antibiotics within 96 hours of randomization

Outcomes

Primary Outcomes

Number of Patients at the Early Assessment Visit With a 20% Reduction in ABSSSI Lesion Size Compared to Baseline

* Did not receive a systemic antibacterial agent with activity against gram-positive organisms * Did not die of any cause up to EA

Time frame: 48-72 hours

Secondary Outcomes

Number of Patients at EOT With a 80% Reduction in ABSSSI Lesion Size Compared to Baseline

Time frame: Day 10

Data from ClinicalTrials.gov

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