Invasive Candidiasis in Critical Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Acute-phase biomarkers dynamics - interleukin-10
研究概览
简要总结
The combination of acute phase marker monitoring and the "T2Candida" assay (name of the test) will represent an acceleration of the identification of the causative agent of mycotic infection, a significant improvement in the specificity and positive predictive value of this strategy in the diagnosis of invasive candidiasis and candidemia in ICU patients, thereby improving the clinical condition of patients and reducing the cost of specific antifungal therapy.
详细描述
Speed of response in the treatment of sepsis is crucial for the patient. The time from the collection of a positive haemoculture to the identification of the causative agent of sepsis is around 2 days; therefore, physicians in intensive care units deploy combined empiric antibiotic and antifungal therapy immediately when acute phase markers such as procalcitonin, interleukin-6, Presepsin, C-reactive protein are elevated. A new acute phase marker is lipopolysaccharide-binding protein, which, together with Presepsin, appears to be a suitable marker to distinguish invasive candida infections from bacterial infections. But its kinetics needs to be further analyzed.
At the same time, the causative agent of sepsis, G-/G+ bacteria or yeast, must be identified as soon as possible. Haemoculture and culture of the established drain is the gold standard, but the disadvantage is the low sensitivity and the time delay to obtain the result. It is therefore advisable to combine haemoculture with molecular biology-based tests that can identify the causative organism within hours. Conversely, the disadvantage of these tests is that they identify only the most common sepsis pathogens and do not determine susceptibility to antibiotics and antifungals, but the advantage is that with prophylaxis in place, these tests are often positive when haemoculture is negative. The T2Candida test can detect Candida albicans, Candida tropicalis, Candida glabrata, Candida krusei and Candida parapsilosis, which are the more common causative agents of mycotic bloodstream infections.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •critically ill patients
- •new onset sepsis
- •rise in body temperature >38°C according to The Third Consensus Definitions for Sepsis and Septic Shock
- •colonization with Candida spp. from more than 1 non-sterile site
- •body temperature >38 °C despite 5 days of broad-spectrum antibiotic therapy with the presence of at least 1 of the following risk factors: abdominal surgery, secondary peritonitis, pancreatitis, central venous catheter (CVC) insertion, total parenteral nutrition (CPV), dialysis, steroid therapy, immunosuppressive therapy, or liver transplantation
- •microbiological test results will be reviewed and categorized based on whether Candida sp. is isolated from at least 2 non-sterile sites (±3 days) and whether there is an alternative microbiological diagnosis.
排除标准
- •not signing the informed consent with participation in the study
- •administration of antifungal therapy prior to collection of the biological material required for the study
结局指标
主要结局
Acute-phase biomarkers dynamics - interleukin-10
时间窗: 8 days
The levels of interleukin-10 will be observed in time and measured in pg/ml. The follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition.
Acute-phase biomarkers dynamics - pentraxin 3
时间窗: 8 days
The levels of C-reactive protein will be observed in time and measured in ng/ml. The follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition.
Lipopolysaccharide binding protein
时间窗: One-time measurement at the enrolment into the study
The levels of Lipopolysaccharide binding protein (LBP)_S/P will be observed in time and measured in mg/L. The follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition.
Acute-phase biomarkers dynamics - 1,3-β-D-glucan
时间窗: 8 days
The levels of C-reactive protein will be observed in time and measured in pg/ml. The follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition.
Acute-phase biomarkers dynamics - Presepsin
时间窗: 8 days
The levels of Presepsin will be observed in time and measured in pg/ml. The follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition.
Acute-phase biomarkers dynamics - procalcitonin
时间窗: 8 days
The levels of procalcitonin will be observed in time and measured in μg/L. The follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition.
Acute-phase biomarkers dynamics - interleukin-6
时间窗: 8 days
The levels of interleukin-6 will be observed in time and measured in pg/ml. The follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition.
Acute-phase biomarkers dynamics - C-reactive protein
时间窗: 8 days
The levels of C-reactive protein will be observed in time and measured in mg/dL. The follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition.
T2Candida test
时间窗: One-time measurement at the enrolment into the study
The T2Candida test is able to detect the presence of Candida albicans, C. tropicalis, C. glabrata, C. krusei and C. parapsilosis. The results will be assessed as positive or negative.
次要结局
未报告次要终点