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

Astellas

Status and phase: Terminated; Phase 3

Conditions: Invasive Fungal Infections

Treatments: Drug: Micafungin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00048750

01-0-124

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Micafungin

2

Placebo Comparator group

Treatment:

Drug: Placebo