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

A Phase 2, Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of MRX-I Versus Linezolid in Adult Subjects With Acute Bacterial Skin and Skin Structure Infection

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 Overview

• Status: Completed
• Conditions: Bacterial Infections
• Intervention / Treatment: Drug: MRX-I; Drug: Linezolid

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRX-I; MRX-I tablets 800 mg given twice a day for 10 days	Drug: MRX-I; Oral MRX-I 800mg given twice a day for 10 days
Active Comparator: Linezolid; Linezolid 600 mg given twice a day for 10 days	Drug: Linezolid; Oral linezolid 600mg given twice a day for 10 days; Other Names: Zyvox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	48-72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Patients at EOT With a 80% Reduction in ABSSSI Lesion Size Compared to Baseline	Day 10

Collaborators and Investigators

• Sponsor: MicuRx

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: October 11, 2014
• First Submitted That Met QC Criteria: October 16, 2014
• First Posted (Estimated): October 21, 2014

Study Record Updates

• Last Update Posted (Actual): November 4, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: ABSSSI; MRX-I; Acute Bacterial Skin and Skin Structure Infections
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Skin Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Infections; Communicable Diseases; Bacterial Infections; Skin Diseases, Bacterial; Anti-Bacterial Agents; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Synthesis Inhibitors; Linezolid
• Other Study ID Numbers: MRX-I-03