β-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients

Duke University

Status: Completed

Conditions: Invasive Candidiasis

Treatments: Drug: Empiric antifungal therapy based on physician discretion.; Drug: Preemptive Therapy with Anidulafungin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00672841

GA88517X

Pro00003161

Details and patient eligibility

About

This is a single center, prospective, open label assessment of β-D-glucan surveillance with preemptive anidulafungin therapy versus standard care for the prevention of invasive candidiasis in at-risk surgical intensive care unit (SICU) patients. Subjects will be stratified by APACHE II score and randomized in 3:1 fashion to either biweekly surveillance using the β-D-glucan assay or standard care. Subjects in the active monitoring arm will receive intravenous anidulafungin should the β-D-glucan exceed 60 pg/mL on a single determination. Subjects in the standard care arm will have biweekly blood draws for β-D-glucan, but the specimens will be batched and tested retrospectively. Antifungal use in the standard care arm is at the discretion of the treating physicians. The primary study end-points are the feasibility of a preemptive antifungal strategy in a SICU setting, β-D-glucan test characteristics, and the safety and tolerability of preemptive anidulafungin. Risks associated with study participation include the risks associated with blood draws, study drug related side effects, and the potential for loss of confidentiality.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Admission to the intensive care unit for ≥ 72 hours and expected to stay an additional 48 hours
• IV access for administration of study drug
• Subject (or subject's legal representative) able to give written informed consent

Exclusion criteria

• History of hypersensitivity or intolerance to echinocandin antifungals
• Liver function test (ALT, AST (aspartate aminotransferase), and/or total bilirubin) greater than 10 times the upper limits of normal (ULN)
• Pregnant or lactating women
• Treatment with systemic antifungal therapy within the preceding 7 days
• Documented invasive fungal infection at baseline/screening
• Life expectancy less than 2 days or moribund

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

2

Active Comparator group

Description:

Standard care/empiric therapy group

Treatment:

Drug: Empiric antifungal therapy based on physician discretion.

1

Experimental group

Description:

Active surveillance/ preemptive therapy group

Treatment:

Drug: Preemptive Therapy with Anidulafungin