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

This study has been terminated.
(Inadequate enrollment)
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00048750
First received: November 6, 2002
Last updated: March 26, 2012
Last verified: March 2008
  Purpose

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 Intervention Phase
Invasive Fungal Infections
Drug: Micafungin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

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 [ Time Frame: Baseline through one week post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of the incidence of patients requiring alternative systemic antifungal therapy to treat suspected infection [ Time Frame: Baseline through one week post-treatment ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: January 2003
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Micafungin
IV
Other Names:
  • Mycamine
  • FK463
Placebo Comparator: 2 Drug: Placebo
IV

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048750

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

Additional Information:
No publications provided

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
Study First Received: November 6, 2002
Last Updated: March 26, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Astellas Pharma Inc:
Anti-Fungal Therapy
Preemptive Anti-Fungal Therapy
Invasive Fungal Infection
Micafungin
ICU

Additional relevant MeSH terms:
Mycoses
Antifungal Agents
Clotrimazole
Miconazole
Micafungin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014