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Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00048750
Recruitment Status : Terminated (Inadequate enrollment)
First Posted : November 8, 2002
Last Update Posted : March 27, 2012
Information provided by:
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Invasive Fungal Infections Drug: Micafungin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : January 2003
Actual Primary Completion Date : June 2003
Actual Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: Micafungin
Other Names:
  • Mycamine
  • FK463

Placebo Comparator: 2 Drug: Placebo

Primary Outcome Measures :
  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 [ Time Frame: Baseline through one week post-treatment ]

Secondary Outcome Measures :
  1. Assessment of the incidence of patients requiring alternative systemic antifungal therapy to treat suspected infection [ Time Frame: Baseline through one week post-treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00048750

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Sponsors and Collaborators
Astellas Pharma Inc
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Study Director: Central Contact Astellas Pharma US, Inc.
Additional Information:
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Responsible Party: Sr Manager Clinical Trials Registry, Astellas Pharma US, Inc. Identifier: NCT00048750    
Other Study ID Numbers: 01-0-124
First Posted: November 8, 2002    Key Record Dates
Last Update Posted: March 27, 2012
Last Verified: March 2008
Keywords provided by Astellas Pharma Inc:
Anti-Fungal Therapy
Preemptive Anti-Fungal Therapy
Invasive Fungal Infection
Additional relevant MeSH terms:
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Invasive Fungal Infections
Antifungal Agents
Anti-Infective Agents