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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00672841
Recruitment Status : Completed
First Posted : May 6, 2008
Results First Posted : April 22, 2013
Last Update Posted : February 6, 2015
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Invasive Candidiasis Drug: Preemptive Therapy with Anidulafungin Drug: Empiric antifungal therapy based on physician discretion. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Active Comparator: 2
Standard care/empiric therapy group
Drug: Empiric antifungal therapy based on physician discretion.
Patients in the standard care group may receive antifungal prophylaxis and/or treatment at any time based on the discretion of the treating physician.

Experimental: 1
Active surveillance/ preemptive therapy group
Drug: Preemptive Therapy with Anidulafungin
Subjects in the active surveillance arm who develop a single positive β-D-glucan test will receive preemptive anidulafungin intravenously. Preemptive therapy will include a loading dose of 200mg followed by 100mg maintenance therapy once a day. The loading and maintenance doses are derived from the FDA cleared schedule for Invasive Candidiasis and candidemia. Preemptive therapy will continue for 14 days.
Other Name: Eraxis

Primary Outcome Measures :
  1. Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients. [ Time Frame: Participants were followed until ICU discharge, an average of 17 days ]
    Clinical utility was defined as β-D-glucan test performance. Biweekly βDG testing used a threshold of ≥ 60 pg/ml to indicate a positive test for invasive candidiasis. True and false positives, and true and false negatives were confirmed using a composite clinical definition of invasive candidiasis that combines physical symptom/signs and microbiology. Cases of proven/probable invasive fungal infection (IFI) were adjudicated by a single reviewer blinded to group assignment and BDG results.

  2. Safety and Tolerability of Preemptive Anidulafungin [ Time Frame: weekly until ICU discharge ]
    reported as the Number of Adverse Events Possibly Related to Study Drug

Secondary Outcome Measures :
  1. Validate Gene Expression Signatures Predictive of IC [ Time Frame: Study Completion, an average of 17 days ]
  2. Incidence of Proven or Probable Invasive Fungal Infection (IFI) [ Time Frame: Participants were followed until ICU discharge, an average of 17 days ]
    Institution specific criteria were used to establish a diagnosis of proven or probable invasive candidiasis. Other IFIs were classified according to the European Organization for Research and Treatment of Cancer/Mycosis Study Group (EORTC/MSG) criteria. However, BDG results were not factored into the EORTC/MSG criteria.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00672841

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
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Principal Investigator: Kimberly E Hanson, MD Utah
Principal Investigator: Barbara D Alexander, MD Duke
Principal Investigator: John Perfect, MD Duke
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Duke University Identifier: NCT00672841    
Other Study ID Numbers: Pro00003161
First Posted: May 6, 2008    Key Record Dates
Results First Posted: April 22, 2013
Last Update Posted: February 6, 2015
Last Verified: November 2012
Keywords provided by Duke University:
invasive candidiasis
preemptive antifungal therapy
β-D-Glucan (BDG)
Additional relevant MeSH terms:
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Candidiasis, Invasive
Invasive Fungal Infections
Antifungal Agents
Anti-Infective Agents
Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors