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

Study Overview
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Brief Summary
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The study is now completed

Detailed Description
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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.

Official Title
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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)

Conditions
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Skin Diseases, Bacterial

Intervention / Treatment
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* Drug: Intravenous iclaprim
* Drug: Intravenous linezolid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intravenous iclaprim|nan|
|Drug: Intravenous linezolid|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological eradication rate at 7-14 days after end of therapy |  |  | 
| Safety evaluations conducted during the study |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin infection, complicated skin infection, skin structure infection, Complicated Skin and Skin Structure Infection