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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

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.

Conditions

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Skin Diseases, Bacterial

Keywords

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skin infection complicated skin infection skin structure infection Complicated Skin and Skin Structure Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Intravenous iclaprim

Intervention Type DRUG

Intravenous linezolid

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Edward Hospital & Health Services

Naperville, Illinois, United States

Site Status

Wyoming Medical Center

Casper, Wyoming, United States

Site Status

Countries

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United States

Other Identifiers

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ASSIST-2

Identifier Type: -

Identifier Source: secondary_id

Protocol No. ICLA-09-CSI2