- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00299520
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)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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California
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National City, California, United States, 91950
- e-Study Site
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Idaho
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Boise, Idaho, United States, 83702
- VA Medical Center
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Indiana
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Indianapolis, Indiana, United States, 46260
- Infectious Disease of Indiana
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Maryland
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Cumberland, Maryland, United States, 21502
- Judith Stone. M.D.
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Ohio
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Toledo, Ohio, United States, 43608
- ID Clinical Research, Ltd.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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
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Secondary Outcome Measures
Outcome Measure |
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Microbiological eradication rate at 7-14 days after end of therapy.
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Safety evaluations conducted during the study
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Disease Attributes
- Bacterial Infections
- Bacterial Infections and Mycoses
- Skin Diseases, Infectious
- Infections
- Communicable Diseases
- Skin Diseases, Bacterial
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Folic Acid Antagonists
- Linezolid
- Iclaprim
Other Study ID Numbers
- Protocol No. ICLA-08-CSI1
- ASSIST-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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