Clinical trial NCT00048750: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Invasive Fungal Infections
Keywords: Anti-Fungal Therapy
Preemptive Anti-Fungal Therapy
Invasive Fungal Infection
Micafungin
ICU
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2002-11-08
Enrollment: 104
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: 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
timeFrame: Baseline through one week post-treatment
Secondary outcomes:
measure: Assessment of the incidence of patients requiring alternative systemic antifungal therapy to treat suspected infection
timeFrame: Baseline through one week post-treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Oakland
country: United States
state: California
city: Orange
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Santa Barbara
country: United States
state: California
city: Stanford
country: United States
state: California
city: Stanford
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Washington D.C.
country: United States
state: District of Columbia
city: Washington
country: United States
state: District of Columbia
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Maywood
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Portland
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Newark
country: United States
state: New Jersey
city: Rochester
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Greenfield Park
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Regina
country: Canada
state: Saskatchewan
city: Saskatoon
country: Canada
state: Saskatchewan
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Central Contact
role: STUDY_DIRECTOR
References: