β-D-Glucan Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients
Information source: Duke University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Invasive Candidiasis
Intervention: Anidulafungin (Drug); Empiric antifungal therapy based on physician discretion. (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Duke University Official(s) and/or principal investigator(s):
Kimberly E Hanson, MD, Principal Investigator, Affiliation: Utah
Barbara D Alexander, MD, Principal Investigator, Affiliation: Duke
John Perfect, MD, Principal Investigator, Affiliation: Duke
Overall contact:
Emma Costea, RN, Phone: 919-668-0789, Email: coste005@mc.duke.edu
Summary
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.
Clinical Details
Official title: Randomized Comparison of β-D-Glucan Surveillance With Preemptive Anidulafungin Versus Standard Care for the Management of Invasive Candidiasis in Surgical Intensive Care Unit Patients
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Assess the clinical feasibility and utility of biweekly β-D-glucan testing as a guide for preemptive antifungal therapy in at-risk surgical intensive care unit (SICU) patients.Evaluate the safety and tolerability of preemptive anidulafungin as compared to current practice (empiric antifungal treatment based on physician discretion) for the management of invasive candidiasis (IC).
Secondary outcome: Validate gene expression signatures predictive of IC
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Emma Costea, RN, Phone: 919-668-0789, Email: coste005@mc.duke.edu
Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Emma Costea, RN, Phone: 919-668-0789, Email: coste005@mc.duke.edu
Barbara D Alexander, MD, Principal Investigator
Kimberly Hanson, MD, Sub-Investigator
John Perfect, MD, Sub-Investigator
Aimee Zaas, MD, Sub-Investigator
Additional Information
Starting date: June 2008
Ending date: August 2009
Last updated: March 30, 2009
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