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

Condition(s) targeted: Skin Diseases, Bacterial

Intervention: Intravenous iclaprim (Drug); Intravenous linezolid (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Arpida AG

The study is now completed

Official title: 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)

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Clinical cure rate (the ratio of number of clinically cured patients to the total number of patients in the population) at 7 to 14 days after the end of therapy

Secondary outcome:

Microbiological eradication rate at 7-14 days after end of therapy

Safety evaluations conducted during the study

Detailed 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.

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

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

Edward Hospital & Health Services, Naperville, Illinois 60540, United States

Wyoming Medical Center, Casper, Wyoming 82601, United States

ARPIDA AG corporate website

Starting date: March 2006
Last updated: March 26, 2007