Back to resultsComparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU
Primary Purpose
Invasive Fungal Infections
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Micafungin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Invasive Fungal Infections focused on measuring Anti-Fungal Therapy, Preemptive Anti-Fungal Therapy, Invasive Fungal Infection, Micafungin, ICU
Eligibility Criteria
Inclusion Criteria Meets entry criteria for high risk Exclusion Criteria 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Assessment of the incidence of patients requiring alternative systemic antifungal therapy to treat suspected infection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00048750
Brief Title
Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Terminated
Why Stopped
Inadequate enrollment
Study Start Date
January 2003 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
June 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Fungal Infections
Keywords
Anti-Fungal Therapy, Preemptive Anti-Fungal Therapy, Invasive Fungal Infection, Micafungin, ICU
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Micafungin
Other Intervention Name(s)
Mycamine, FK463
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IV
Primary Outcome Measure Information:
Title
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
Time Frame
Baseline through one week post-treatment
Secondary Outcome Measure Information:
Title
Assessment of the incidence of patients requiring alternative systemic antifungal therapy to treat suspected infection
Time Frame
Baseline through one week post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Meets entry criteria for high risk
Exclusion Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93102
Country
United States
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
City
Washington D.C.
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33601
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46390
Country
United States
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27110
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22906
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4P 0W5
Country
Canada
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N0W8
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrials.jp/user/ctrDetail_e.jsp?resultId=342
Description
Link to results on JAPIC
Learn more about this trial
Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU
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