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

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ClinicalTrials.gov Identifier: NCT00048750
Recruitment Status : Terminated (Inadequate enrollment)
First Posted : November 8, 2002
Last Update Posted : March 27, 2012
Sponsor:
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

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

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Micafungin
IV
Other Names:
  • Mycamine
  • FK463
Placebo Comparator: 2 Drug: Placebo
IV



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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT00048750


  Show 49 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Central Contact Astellas Pharma US, Inc.

Additional Information:
Responsible Party: Sr Manager Clinical Trials Registry, Astellas Pharma US, Inc.
ClinicalTrials.gov Identifier: NCT00048750     History of Changes
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
Micafungin
ICU

Additional relevant MeSH terms:
Mycoses
Invasive Fungal Infections
Antifungal Agents
Miconazole
Micafungin
Echinocandins
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors