Clinical trial NCT00672841: β-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Invasive Candidiasis
Keywords: candidemia
invasive candidiasis
preemptive antifungal therapy
surveillance
β-D-Glucan (BDG)
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-05-06
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients.
timeFrame: Participants were followed until ICU discharge, an average of 17 days
measure: Safety and Tolerability of Preemptive Anidulafungin
timeFrame: weekly until ICU discharge
Secondary outcomes:
measure: Validate Gene Expression Signatures Predictive of IC
timeFrame: Study Completion, an average of 17 days
measure: Incidence of Proven or Probable Invasive Fungal Infection (IFI)
timeFrame: Participants were followed until ICU discharge, an average of 17 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Utah
name: Kimberly E Hanson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke
name: Barbara D Alexander, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke
name: John Perfect, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hanson KE, Pfeiffer CD, Lease ED, Balch AH, Zaas AK, Perfect JR, Alexander BD. beta-D-glucan surveillance with preemptive anidulafungin for invasive candidiasis in intensive care unit patients: a randomized pilot study. PLoS One. 2012;7(8):e42282. doi: 10.1371/journal.pone.0042282. Epub 2012 Aug 6.