Study Stopped
Inadequate enrollment
Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU
A Phase 3, Randomized,Double-Blind, Comparative Study of Micafungin (FK463) Versus Placebo as Preemptive Prophylactic Antifungal Therapy in Patients in the Intensive Care Unit
1 other identifier
interventional
104
2 countries
48
Brief Summary
The purpose of this study is to determine the efficacy and safety of intravenous micafungin versus placebo as prophylactic therapy for invasive fungal infections in patients in the intensive care unit considered to be at high risk.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2003
Shorter than P25 for phase_3
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2002
CompletedFirst Posted
Study publicly available on registry
November 8, 2002
CompletedStudy Start
First participant enrolled
January 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2003
CompletedMarch 27, 2012
March 1, 2008
5 months
November 6, 2002
March 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of the incidence of a proven or probable invasive fungal infection, catheter tip fungal infection, or deep incisional surgical site infection during the study
Baseline through one week post-treatment
Secondary Outcomes (1)
Assessment of the incidence of patients requiring alternative systemic antifungal therapy to treat suspected infection
Baseline through one week post-treatment
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Meets entry criteria for high risk
You may not qualify if:
- Evidence of active invasive fungal infection
- Received more than one dose of systemic antifungal agent within 72 hours prior to first dose of study drug
- Known to be HIV positive who have CD4 count less than 500 cells/mm3
- Has life-expectancy of less than 72 hours or moribund
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Los Angeles, California, 90033, United States
Unknown Facility
Los Angeles, California, 90048, United States
Unknown Facility
Oakland, California, 94609, United States
Unknown Facility
Orange, California, 92868, United States
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
San Francisco, California, 94110, United States
Unknown Facility
Santa Barbara, California, 93102, United States
Unknown Facility
Stanford, California, 94304, United States
Unknown Facility
Stanford, California, 94305, United States
Unknown Facility
Denver, Colorado, 80262, United States
Unknown Facility
Washington D.C., District of Columbia, 20010, United States
Unknown Facility
Tampa, Florida, 33601, United States
Unknown Facility
Atlanta, Georgia, 30303, United States
Unknown Facility
Maywood, Illinois, 60153, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Indianapolis, Indiana, 46390, United States
Unknown Facility
Portland, Maine, 04102, United States
Unknown Facility
Baltimore, Maryland, 21201, United States
Unknown Facility
Baltimore, Maryland, 21287, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
Detroit, Michigan, 48201, United States
Unknown Facility
Minneapolis, Minnesota, 55455, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Omaha, Nebraska, 68198, United States
Unknown Facility
Newark, New Jersey, 07103, United States
Unknown Facility
Rochester, New York, 14642, United States
Unknown Facility
Durham, North Carolina, 27110, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Cincinnati, Ohio, 45267, United States
Unknown Facility
Hershey, Pennsylvania, 17033, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15213, United States
Unknown Facility
Nashville, Tennessee, 37212, United States
Unknown Facility
Dallas, Texas, 75246, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Salt Lake City, Utah, 84132, United States
Unknown Facility
Charlottesville, Virginia, 22906, United States
Unknown Facility
Seattle, Washington, 98104, United States
Unknown Facility
Hamilton, Ontario, L8V 1C3, Canada
Unknown Facility
London, Ontario, N6A 5A5, Canada
Unknown Facility
Ottawa, Ontario, K1H 8L6, Canada
Unknown Facility
Greenfield Park, Quebec, J4V 2H1, Canada
Unknown Facility
Montreal, Quebec, H3A 1A1, Canada
Unknown Facility
Regina, Saskatchewan, S4P 0W5, Canada
Unknown Facility
Saskatoon, Saskatchewan, S7N0W8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma US, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 6, 2002
First Posted
November 8, 2002
Study Start
January 1, 2003
Primary Completion
June 1, 2003
Study Completion
June 1, 2003
Last Updated
March 27, 2012
Record last verified: 2008-03