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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00299520
Recruitment Status : Completed
First Posted : March 7, 2006
Last Update Posted : April 4, 2008
Sponsor:
Information provided by:
Arpida AG

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Complicated Skin and Skin Structure Infection Drug: intravenous iclaprim or intravenous linezolid Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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-1)
Study Start Date : June 2005
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Linezolid

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Microbiological eradication rate at 7-14 days after end of therapy.
  2. Safety evaluations conducted during the study

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00299520


Locations
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United States, California
e-Study Site
National City, California, United States, 91950
United States, Idaho
VA Medical Center
Boise, Idaho, United States, 83702
United States, Indiana
Infectious Disease of Indiana
Indianapolis, Indiana, United States, 46260
United States, Maryland
Judith Stone. M.D.
Cumberland, Maryland, United States, 21502
United States, Ohio
ID Clinical Research, Ltd.
Toledo, Ohio, United States, 43608
Sponsors and Collaborators
Arpida AG
More Information
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00299520    
Other Study ID Numbers: Protocol No. ICLA-08-CSI1
ASSIST-1
First Posted: March 7, 2006    Key Record Dates
Last Update Posted: April 4, 2008
Last Verified: April 2008
Keywords provided by Arpida AG:
skin infection
complicated skin infection
skin structure infection
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Skin Diseases, Bacterial
Disease Attributes
Pathologic Processes
Bacterial Infections
Bacterial Infections and Mycoses
Skin Diseases, Infectious
Skin Diseases
 Linezolid
Iclaprim
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists