Study of Intravenous (I.V.) Iclaprim Versus Linezolid in Complicated Skin and Skin Structure Infections [cSSSI] (ASSIST-2)

Phase 3, Randomized, Investigator-Blind, Multi-Center Study to Evaluate Efficacy and Safety of Intravenous Iclaprim Versus Linezolid in Complicated Skin and Skin Structure Infections (ASSIST-2)

The study is now completed

Primary Objective:

The primary objective of this study is to compare the clinical cure rates of iclaprim and linezolid at the test of cure (TOC) visit (7 to 14 days after the end of treatment).

Secondary Objectives:

The secondary objectives of this study are to compare iclaprim with linezolid regarding:

• Clinical efficacy at the end of study medication treatment;
• Time to resolution of systemic and local signs and symptoms of complicated skin and skin structure infection (cSSSI);
• Clinical outcome in the microbiologically evaluable (ME) population;
• Bacteriologic outcome in the ME population;
• Bacteriologic eradication rates of Baseline (BL) pathogens;
• Clinical outcome in the modified intent-to-treat (MITT) population;
• Bacteriologic outcome in the MITT population;
• Baseline in vitro susceptibility of isolated pathogens in the ME population; and
• Safety and tolerability of iclaprim treatment.

Inclusion Criteria:

• Diagnosis of an infection consistent with complicated skin and skin structure infection due to a gram positive pathogen.

Exclusion Criteria:

• Known or suspected hypersensitivity to any study medication or other related anti-infective medication
• Any known or suspected condition or concurrent treatment contraindicated by the prescribing information
• Previous enrollment in this study
• Treatment with any investigational drug within 30 days before enrollment