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

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00048750

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 III

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:

MedlinePlus related topics: Fungal Infections Molds

Drug Information available for: FK 463 Micafungin

U.S. FDA Resources

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

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

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:	September 29, 2008
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
Micafungin

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012