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

This study has been completed.
Sponsor:
Information provided by:
Arpida AG
ClinicalTrials.gov Identifier:
NCT00303550
First received: March 15, 2006
Last updated: March 26, 2007
Last verified: March 2006
  Purpose

The study is now completed


Condition Intervention Phase
Skin Diseases, Bacterial
Drug: Intravenous iclaprim
Drug: Intravenous linezolid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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-2)

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

ClinicalTrials.gov Identifier: NCT00303550     History of Changes
Other Study ID Numbers: Protocol No. ICLA-09-CSI2, ASSIST-2
Study First Received: March 15, 2006
Last Updated: March 26, 2007
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:
Infection
Communicable Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Linezolid
Iclaprim
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists

ClinicalTrials.gov processed this record on September 18, 2014