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

Invasive Fungal Infections Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00048750
• Other study ID #: 01-0-124
• Status: Terminated
• Phase: Phase 3
• First received: November 6, 2002
• Last updated: March 26, 2012
• Start date: January 2003
• Est. completion date: June 2003

Study information

• Verified date: March 2008
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 104
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Invasive Fungal Infections
• Mycoses

Intervention

Drug:
• Micafungin
IV
• Placebo
IV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Baseline through one week post-treatment	No
Secondary	Assessment of the incidence of patients requiring alternative systemic antifungal therapy to treat suspected infection		Baseline through one week post-treatment	No

External Links

•   Link to results on JAPIC