NCT00520234

Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU)

A Randomized, Double-blind, Placebo Controlled Trial of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in High-risk Adults in the Critical Care Setting

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Mycoses Study Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Adults admitted to intensive care units are at risk for a variety of complications. Infections due to the fungus called candida are of particular concern. The study will test the possibility that caspofungin, a new therapy for fungal infections, can successfully reduce the rate of candida infections in subjects at risk. It will also test if caspofungin is useful in treating subjects for this disease when diagnosed using a new blood test that is performed twice weekly, permitting earlier diagnosis than current practice standards.

Conditions

• Invasive Candidiasis

Interventions

Type	Name	Description
DRUG	Caspofungin	50 mg IV daily
DRUG	Normal Saline	100 cc IV daily

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2007-08-23
• Last updated: 2011-05-09
• Results posted: 2011-05-09

Locations

12 sites across 1 country: United States