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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00048750

Enrollment

104

Registered

2002-11-08

Start date

2003-01-31

Completion date

2003-06-30

Last updated

2012-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Fungal Infections

Keywords

Anti-Fungal Therapy, Preemptive Anti-Fungal Therapy, Invasive Fungal Infection, Micafungin, ICU

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.

Interventions

DRUGMicafungin

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
Assessment of the incidence of patients requiring alternative systemic antifungal therapy to treat suspected infection	Baseline through one week post-treatment

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026