Status:
COMPLETED
Phase 3 Safety and Efficacy Study of I.V. Iclaprim v Linezolid in cSSSI (ASSIST-1)
Lead Sponsor:
Arpida AG
Conditions:
Complicated Skin and Skin Structure Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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). Seco...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00299520
Start Date
June 1 2005
End Date
July 1 2006
Last Update
April 4 2008
Active Locations (5)
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1
e-Study Site
National City, California, United States, 91950
2
VA Medical Center
Boise, Idaho, United States, 83702
3
Infectious Disease of Indiana
Indianapolis, Indiana, United States, 46260
4
Judith Stone. M.D.
Cumberland, Maryland, United States, 21502