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

This study has been completed.
Sponsor:
Information provided by:
Arpida AG
ClinicalTrials.gov Identifier:
NCT00299520
First received: March 3, 2006
Last updated: April 2, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Complicated Skin and Skin Structure Infection
Drug: intravenous iclaprim or 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-1)

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: June 2005
Estimated Study Completion Date: July 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 and older
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: NCT00299520

Locations
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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00299520     History of Changes
Other Study ID Numbers: Protocol No. ICLA-08-CSI1, ASSIST-1
Study First Received: March 3, 2006
Last Updated: April 2, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Arpida AG:
skin infection
complicated skin infection
skin structure infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
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 30, 2014