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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
2
Standard care/empiric therapy group
干预措施: Empiric antifungal therapy based on physician discretion. (Drug)
1
Active surveillance/ preemptive therapy group
干预措施: Preemptive Therapy with Anidulafungin (Drug)
结局指标
主要结局
Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients.
时间窗: 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
时间窗: weekly until ICU discharge
reported as the Number of Adverse Events Possibly Related to Study Drug
次要结局
- Validate Gene Expression Signatures Predictive of IC(Study Completion, an average of 17 days)
- Incidence of Proven or Probable Invasive Fungal Infection (IFI)(Participants were followed until ICU discharge, an average of 17 days)