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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mycoses Study Group
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Caspofungin; Echinocandins

Criteria

Inclusion Criteria:

• Non-pregnant >18 yrs of age

• Subjects admitted to ICU during the preceding 3 days and expected to stay in the ICU for at least another 48 hours.Subjects can be enrolled on days 3-5 of ICU admission.

• Subjects meeting the clinical prediction rule

Exclusion Criteria:

• Subjects with an allergy/intolerance to caspofungin or echinocandin analog

• absolute neutrophil count <500/mm3 at study entry or likely to develop such a count during therapy

• acquired immunodeficiency syndrome, aplastic anemia or chronic granulomatous disease

• moderate or severe hepatic insufficiency

• subjects who are pregnant or lactating

• unlikely to survive < 24 hours

• subjects who have received systemic antifungal therapy within 10 days prior to study entry

• Documented active proven or probable invasive fungal infection upon enrollment

• previously enrolled in this study

• Currently on another investigational agent or have received an investigational agent within 10 days prior to study entry.