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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Comparison of β-D-Glucan Surveillance With Preemptive Anidulafungin Versus Standard Care for the Management of Invasive Candidiasis in Surgical Intensive C

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.

Detailed Summary:
Sponsor: Duke University

Current Primary Outcome:

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


Original 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. [ Time Frame: study completion ]
  • 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). [ Time Frame: study completion ]


Current Secondary Outcome:

  • Validate Gene Expression Signatures Predictive of IC [ Time Frame: Study Completion, an average of 17 days ]
  • 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.


Original Secondary Outcome: Validate Gene Expression Signatures Predictive of IC [ Time Frame: Study Completion ]

Information By: Duke University

Dates:
Date Received: May 4, 2008
Date Started: June 2008
Date Completion:
Last Updated: January 20, 2015
Last Verified: November 2012