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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Invasive Fungal Infections

In brief

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.

Key facts

Study ID

NCT00048750

Run by

Astellas Pharma Inc

People needed

104

Starts

2003-01-01

Expected to finish

2003-06-01

Last updated by the study team

2012-03-27

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets entry criteria for high risk

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Oakland, California, United States
• Study site — Orange, California, United States
• Study site — Sacramento, California, United States
• Study site — San Francisco, California, United States
• Study site — Santa Barbara, California, United States
• Study site — Stanford, California, United States
• Study site — Stanford, California, United States
• Study site — Denver, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Maywood, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Portland, Maine, United States
• Study site — Baltimore, Maryland, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.