Back to resultsPhase 3 Safety and Efficacy Study of I.V. Iclaprim v Linezolid in cSSSI (ASSIST-1)
Primary Purpose
Complicated Skin and Skin Structure Infection
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
intravenous iclaprim or intravenous linezolid
Sponsored by
About this trial
This is an interventional treatment trial for Complicated Skin and Skin Structure Infection focused on measuring skin infection, complicated skin infection, skin structure infection
Eligibility 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
Sites / Locations
- e-Study Site
- VA Medical Center
- Infectious Disease of Indiana
- Judith Stone. M.D.
- ID Clinical Research, Ltd.
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00299520
Brief Title
Phase 3 Safety and Efficacy Study of I.V. Iclaprim v Linezolid in cSSSI (ASSIST-1)
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 Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Arpida AG
4. Oversight
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complicated Skin and Skin Structure Infection
Keywords
skin infection, complicated skin infection, skin structure infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
intravenous iclaprim or intravenous linezolid
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Microbiological eradication rate at 7-14 days after end of therapy.
Title
Safety evaluations conducted during the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
e-Study Site
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
VA Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Infectious Disease of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Judith Stone. M.D.
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
ID Clinical Research, Ltd.
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.arpida.ch
Description
ARPIDA AG corporate website
Learn more about this trial
Phase 3 Safety and Efficacy Study of I.V. Iclaprim v Linezolid in cSSSI (ASSIST-1)
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