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

Tracking Information

First Received Date ^ICMJE

November 6, 2002

Last Updated Date

September 29, 2008

Start Date ^ICMJE

January 2003

Primary Completion Date

June 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00048750 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Invasive Fungal Infections

Intervention ^ICMJE

Drug: Micafungin
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

104

Completion Date

June 2003

Primary Completion Date

June 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00048750

Responsible Party

Sr Manager Clinical Trials Registry, Astellas Pharma US, Inc.

Study ID Numbers ^ICMJE

01-0-124

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Central Contact

Astellas Pharma US, Inc.

Information Provided By

Astellas Pharma Inc

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP