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Completed

NCT Number: NCT00672841

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

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.

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Key information

Conditions

Invasive Candidiasis Bacterial Infections and Mycoses Candidemia Candidiasis Candidiasis, Invasive Fungemia Infections Inflammation Invasive Fungal Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preemptive Therapy with Anidulafungin

Drug

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 names: Eraxis

Empiric antifungal therapy based on physician discretion.

Drug

Patients in the standard care group may receive antifungal prophylaxis and/or treatment at any time based on the discretion of the treating physician.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Pfizer

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
May 6, 2008
Registry last updated
Feb 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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