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

Sponsor:	Arpida AG
Information provided by:	Arpida AG
ClinicalTrials.gov Identifier:	NCT00303550

Purpose

The study is now completed

Condition	Intervention	Phase
Skin Diseases, Bacterial	Drug: Intravenous iclaprim Drug: Intravenous linezolid	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:

MedlinePlus related topics: Skin Conditions Skin Infections

Drug Information available for: Linezolid Iclaprim

U.S. FDA Resources

Further study details as provided by Arpida AG:

Primary Outcome Measures:

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:

Microbiological eradication rate at 7-14 days after end of therapy
Safety evaluations conducted during the study

Study Start Date:

March 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303550

Locations

United States, Illinois
Edward Hospital & Health Services
Naperville, Illinois, United States, 60540
United States, Wyoming
Wyoming Medical Center
Casper, Wyoming, United States, 82601

Sponsors and Collaborators

Arpida AG

More Information

Additional Information:

ARPIDA AG corporate website This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	Protocol No. ICLA-09-CSI2, ASSIST-2
Study First Received:	March 15, 2006
Last Updated:	March 26, 2007
ClinicalTrials.gov Identifier:	NCT00303550 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Arpida AG:

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

Additional relevant MeSH terms:

Bacterial Infections
Protein Synthesis Inhibitors
Anti-Infective Agents
Skin Diseases, Infectious
Molecular Mechanisms of Pharmacological Action
Skin Diseases

Therapeutic Uses
Skin Diseases, Bacterial
Enzyme Inhibitors
Infection
Linezolid
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010