Phase 3 Safety and Efficacy Study of I.V. Iclaprim v Linezolid in cSSSI (ASSIST-1)
Information source: Arpida AG
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Complicated Skin and Skin Structure Infection
Intervention: intravenous iclaprim or intravenous linezolid (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Arpida AG
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).
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: Microbiological eradication rate at 7-14 days after end of therapy.Safety evaluations conducted during the study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
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
Additional Information
ARPIDA AG corporate website
Starting date: June 2005
Ending date: July 2006
Last updated: April 2, 2008
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