A Phase 3 interventional study of intravenous iclaprim or intravenous linezolid in Complicated Skin and Skin Structure Infection, sponsored by Arpida AG. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-04-04.
Sponsored by Arpida AG · Phase 3, Interventional, and Treatment
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).
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:
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
Browse Infections studies →Arpida AG is the lead sponsor of 3 studies on the registry; none are open to participants now.
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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
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
Microbiological eradication rate at 7-14 days after end of therapy.
Safety evaluations conducted during the study
This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.
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Arpida AG