Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study (ICE)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Invasive Candidiasis

Treatments: Drug: Voriconazole; Drug: Fluconazole; Drug: Anidulafungin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00689338

A8851019

Details and patient eligibility

About

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

Enrollment: 216 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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216 participants in 1 patient group

Treatment Group

Experimental group

Description:

Option to treat with oral azole therapy following treatment with anidulafungin

Treatment:

Drug: Fluconazole

Drug: Voriconazole

Drug: Anidulafungin