Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal infections in intensive care and critical care unit patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Anidulafungin; Echinocandins; Fluconazole; Voriconazole

Criteria

Inclusion Criteria:

ICU patients with a diagnosis of documented candidemia or invasive candidiasis and belonging to one or more of the following specific populations:

• Post-abdominal surgery.

• Elderly > 65 years old.

• Renal insufficiency / failure / hemodialysis.

• Solid tumor.

• Solid-organ (liver, kidney, lung, heart) transplant recipients.

• Hepatic insufficiency.

• Neutropenic including hematology oncology patients.

Exclusion Criteria:

Patients with poor venous access that would preclude IV drug delivery or multiple blood draws.