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)
2 other identifiers
interventional
N/A
1 country
2
Brief Summary
The study is now completed
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 15, 2006
CompletedFirst Posted
Study publicly available on registry
March 17, 2006
CompletedMarch 27, 2007
March 1, 2006
March 15, 2006
March 26, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Microbiological eradication rate at 7-14 days after end of therapy
Safety evaluations conducted during the study
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of an infection consistent with complicated skin and skin structure infection due to a gram positive pathogen.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arpida AGlead
Study Sites (2)
Edward Hospital & Health Services
Naperville, Illinois, 60540, United States
Wyoming Medical Center
Casper, Wyoming, 82601, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 15, 2006
First Posted
March 17, 2006
Study Start
March 1, 2006
Last Updated
March 27, 2007
Record last verified: 2006-03