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

Skin Diseases, Bacterial Clinical Trial

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)

Status Completed

Clinical Trial Summary

The study is now completed

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Skin Diseases
• Skin Diseases, Bacterial

• NCT number: NCT00303550
• Study type: Interventional
• Source: Arpida AG
• Status: Completed
• Phase: Phase 3
• Start date: March 2006