(1,3)-β-D-glucan Based Diagnosis of Invasive Candida Infection Versus Culture Based Diagnosis in Patients With Severe Sepsis or Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 342
- 试验地点
- 29
- 主要终点
- 28 day mortality
研究概览
简要总结
This prospective randomized multicenter study evaluates whether the decision to prescribe antifungals guided by (1,3)-β-D-glucan in comparison to standard of care shortens time to antifungal therapy and reduces mortality in patients with severe sepsis or septic shock and a high risk of invasive candida infection.
详细描述
(1,3)-β-D-glucan is a component of the cell wall of many fungi including candida spp. and is present in the blood of patients with invasive candida infection (ICI). Several studies showed a good diagnostic accuracy (1,3)-β-D-glucan in predicting ICI. However, others have challenged (1,3)-β-D-glucan as a diagnostic tool in critically ill patients as many substances used in the intensive care unit might affect the results of the assay. The goal of this study is to investigate whether (1,3)-β-D-glucan can early identify sepsis patients in need of antifungal therapy. Patients randomized to the standard of care group receive antifungals depending on microbiological results according to current guidelines. Patients randomized to the BDG group receive antifungals depending on the (1,3)-β-D-glucan plasma concentration on day 1 and day after diagnosing sepsis. Therapy may be modified according to microbiological results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Severe sepsis or septic shock
- •Onset of sepsis no longer than 24 hours
- •Increased risk of invasive candida infection with at least one of the following criteria:
- •total parenteral nutrition ≥48 hours
- •abdominal surgery within the last 7 days
- •antimicrobial therapy for at least 48 hours within the last 7 days
- •Acute or chronic renal failure with renal replacement therapy
- •Age ≥18 years
- •Informed consent of the patient or legal representative or delayed consent process is started if patient is incapable of giving informed consent and no legal representative is available.
排除标准
- •Pregnant or lactating women
- •Ongoing invasive candida infection
- •systemic antifungal therapy
- •liver cirrhosis Child C
- •cardiopulmonary bypass within the last 4 weeks
- •treatment with immunoglobulins within the last 14 days
- •immunosuppression (solid organ transplantation, AISA, leukopenia)
- •participation in another intervention study
- •no commitment to full therapy (i.e. DNR order)
- •Infauste Prognose aufgrund von Nebenerkrankungen
- •kin to or colleague of study personnel
结局指标
主要结局
28 day mortality
时间窗: 28 days
次要结局
- Adverse events(14 days)
- Diagnostic performance of (1,3)-β-D-glucan in comparison to PCR and other experimental diagnostics(2 days)
- Pharmacoeconomics(14 days)
- 28 day antifungal-free survival(28 days)
- Candida Colonization(14 days)
- Duration of organ support(14 days)
- ICU and hospital mortality(Hospital length of stay)
- Time to antifungal therapy(14 days)
- Mean total SOFA score(14 days)
- ICU and hospital length of stay(Hospital length of stay)