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
Number of patients with adverse events as a measure of safety and tolerability	Changes in vital signs, ECG parameters and laboratory data	Screening though Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of MITT patients at the early assessment visit with a 20% reduction in ABSSSI lesion size compared to baseline		48-72 hours
Number of patients at EOT with a 80% reduction in ABSSSI lesion size compared to baseline		Day 10
Number of patients with resolution or near resolution of most baseline ABSSSI symptoms and signs absence or near absence of systemic signs of infection at Post Trial Assessment		7-14 days after the End of Therapy
Number of patients with a microbiological outcome of eradication or presumed eradication at Post Trial Assessment		7-14 days after the End of Therapy
Population PK of MRX-I Tablets	• Influence of baseline subject characteristics on blood levels of MRX-I	Day 3 and Day 7

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): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• 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; Skin Diseases; Disease Attributes; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Infections; Communicable Diseases; Bacterial Infections; Skin Diseases, Bacterial; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Linezolid
• Other Study ID Numbers: MRX-I-03