Phase 3 Safety and Efficacy Study of I.V. Iclaprim v Linezolid in cSSSI (ASSIST-1)

Study Overview
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Brief Summary
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This is a multi-center, investigator-blind, comparative Phase 3 study. Patients will receive either iclaprim or linezolid for 10 to 14 days. Patients will be evaluated daily for the first four days of study treatment and then every other day, for up to 14 days of the treatment period, at End of Therapy, the Test Of Cure visit (7 to 14 days post treatment), and a Late Follow-up (F/U) visit (7 to 14 days after the TOC visit).

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-1)

Conditions
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Complicated Skin and Skin Structure Infection

Intervention / Treatment
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* Drug: intravenous iclaprim or 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

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 or 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