Clinical trial

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

Name

MRX-I-03

Description

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

Trial arms

Trial start

2015-02-01

Estimated PCD

2015-08-01

Trial end

2015-09-01

Status

Completed

Phase

Early phase I

Treatment

MRX-I

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

Arms:

MRX-I

Linezolid

Oral linezolid 600mg given twice a day for 10 days

Arms:

Linezolid

Other names:

Zyvox

Size

120

Primary endpoint

Number of patients at the early assessment visit with a 20% reduction in ABSSSI lesion size compared to baseline

48-72 hours

Number of patients with adverse events as a measure of safety and tolerability

Screening though Day 28

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ACTUAL'}}

Updated at

2023-08-31

1 organization

2 products

1 indication

Organization

Product

Indication

Product