Phase 3 Safety and Efficacy Study of I.V. Iclaprim v Linezolid in cSSSI (ASSIST-1)
NCT ID: NCT00299520
Last Updated: 2008-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
2005-06-30
2006-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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intravenous iclaprim or intravenous linezolid
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Arpida AG
INDUSTRY
Locations
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e-Study Site
National City, California, United States
VA Medical Center
Boise, Idaho, United States
Infectious Disease of Indiana
Indianapolis, Indiana, United States
Judith Stone. M.D.
Cumberland, Maryland, United States
ID Clinical Research, Ltd.
Toledo, Ohio, United States
Countries
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Related Links
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ARPIDA AG corporate website
Other Identifiers
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ASSIST-1
Identifier Type: -
Identifier Source: secondary_id
Protocol No. ICLA-08-CSI1
Identifier Type: -
Identifier Source: org_study_id