Phase 3 Safety and Efficacy Study of I.V. Iclaprim v Linezolid in cSSSI (ASSIST-1)
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)
2 other identifiers
interventional
N/A
1 country
5
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2005
Shorter than P25 for phase_3
5 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
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 3, 2006
CompletedFirst Posted
Study publicly available on registry
March 7, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedApril 4, 2008
April 1, 2008
March 3, 2006
April 2, 2008
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arpida AGlead
Study Sites (5)
e-Study Site
National City, California, 91950, United States
VA Medical Center
Boise, Idaho, 83702, United States
Infectious Disease of Indiana
Indianapolis, Indiana, 46260, United States
Judith Stone. M.D.
Cumberland, Maryland, 21502, United States
ID Clinical Research, Ltd.
Toledo, Ohio, 43608, 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 3, 2006
First Posted
March 7, 2006
Study Start
June 1, 2005
Study Completion
July 1, 2006
Last Updated
April 4, 2008
Record last verified: 2008-04