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

Arpida

Status and phase

Completed

Phase 3

Conditions

Skin Diseases, Bacterial

Treatments

Drug: Intravenous linezolid

Drug: Intravenous iclaprim

Study type

Interventional

Funder types

Industry

Identifiers

NCT00303550

Protocol No. ICLA-09-CSI2

ASSIST-2

Details and patient eligibility

About

The study is now completed

Full description

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.

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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