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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00303550
First Posted: March 17, 2006
Last Update Posted: March 27, 2007
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.
Information provided by:
Arpida AG
March 15, 2006
March 17, 2006
March 27, 2007
March 2006
Not Provided
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
  • Primary:
  • 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
Complete list of historical versions of study NCT00303550 on ClinicalTrials.gov Archive Site
  • Microbiological eradication rate at 7-14 days after end of therapy
  • Safety evaluations conducted during the study
  • Secondary:
  • Microbiological eradication rate at 7-14 days after end of therapy.
  • Safety evaluations conducted during the study
Not Provided
Not Provided
 
Study of Intravenous (I.V.) Iclaprim Versus Linezolid in Complicated Skin and Skin Structure Infections [cSSSI] (ASSIST-2)
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)
The study is now completed

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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Skin Diseases, Bacterial
  • Drug: Intravenous iclaprim
  • Drug: Intravenous linezolid
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00303550
Protocol No. ICLA-09-CSI2
ASSIST-2
Not Provided
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Arpida AG
Not Provided
Not Provided
Arpida AG
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP