Trial | NCT02269319  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    120
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 Started
Feb 28
2015
Primary Completion
Aug 31
2015
Study Completion
Sep 30
2015
Last Update
Aug 31
2023

Drug MRX-I

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

Drug Linezolid

Oral linezolid 600mg given twice a day for 10 days

  • Other names: Zyvox

MRX-I Experimental

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

Linezolid Active Comparator

Linezolid 600 mg given twice a day for 10 days

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
No Results Posted