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

Phase 3TerminatedNCT00048750

Astellas Pharma Inc104 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

104

Conditions

Invasive Fungal Infections

Interventions

MicafunginDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (48)

Outcomes

Primary Outcomes

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 Outcomes

Assessment of the incidence of patients requiring alternative systemic antifungal therapy to treat suspected infection

Time frame: Baseline through one week post-treatment

Data from ClinicalTrials.gov

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Birmingham, Alabama, United States

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Little Rock, Arkansas, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Oakland, California, United States

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Orange, California, United States

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Sacramento, California, United States

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San Francisco, California, United States

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Santa Barbara, California, United States

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Stanford, California, United States

...and 38 more locations