Expired Study
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Durham, North Carolina 27710


Purpose:

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.


Criteria:

Inclusion Criteria: - Age ≥18 years - Admission to the SICU 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, 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 IFI at baseline/screening - Life expectancy less than 2 days or moribund


NCT ID:

NCT00672841


Primary Contact:

Principal Investigator
Kimberly E Hanson, MD
Utah


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27710
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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