A Pilot Study for the Use of Biomarkers and Early Treatment of Invasive Candidiasis in ICU Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin
研究概览
简要总结
This is a prospective study aimed at testing a strategy of early initiation of an antifungal agent to patients admitted to intensive care units (ICUs) at risk for invasive candidiasis. Score system have been developed to identify groups at very high risk for the development of candidemia/invasive candidiasis in the ICU. These scoring system have used clinical information with or without data on Candida colonization, and have shown reasonable correlation with candidemia/invasive candidiasis. More recently, a biomarker - detection of 1,3-beta-D-glucan in the serum - has been tested in the early diagnosis of candidiasis. The incorporation of biomarkers such as beta-D-glucan could help clinicians to select a group at higher risk for candidemia, and despite the fact that these tests may give false-positive results, their negative predictive value could be of great help.
Therefore, the objectives of this study are:
- To assess the frequency of positive biomarkers in ICU patients at high risk to develop invasive candidiasis/candidemia;
- To test the strategy of early discontinuation of antifungal therapy based on repeatedly negative blood cultures and 1,3 beta-D-glucan in the serum.
详细描述
Entry criteria are: In the ICU for >2 days AND systemic antibiotics >2 days OR central venous catheter for >days AND at least two of the following: total parenteral nutrition, dialysis, surgery, pancreatitis, receipt of corticosteroids, receipt of other immunosuppressive agents. In addition, patients must have a clinical sign of infection (either one of the following): fever, hypothermia, hypotension, unexplained acidosis, or unexplained elevation in C-reactive protein.
Eligible patients will be enrolled after signing an informed consent and will have blood obtained for culture and determination of 1,3 beta-D-glucan serum levels for 3 days, and will start anidulafungin IV.
If all tests are negative, anidulafungin will be discontinued on day 4. If 1,3 beta-D-glucan is positive (>80 pg/ml) and / or blood cultures are positive for Candida species, anidulafungin will be continued for >14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •In the ICU for >2 days AND
- •Systemic antibiotics on days 1-3 of ICU OR
- •Central venous catheter on days 1-3 of ICU
- •AND at least 2 of:
- •Total parenteral nutrition on days 1-3 of ICU
- •Any dialysis on days 1-3 of ICU
- •Major surgery in the 7 days before admission in the ICU
- •Pancreatitis in the 7 days before admission in the ICU
- •Use of corticosteroids for at least 3 days in the 7 days before admission
- •Use of other immunosuppressive agents in the 7 days before admission in the ICU
- •In addition, the patient must have at least one of the following:
- •Fever (axillary temperature >37.5 oC)
- •Hypothermia (axillary temperature <35 oC)
- •Hypotension
- •Unexplained acidosis
- •Unexplained elevation in C-reactive protein
排除标准
- •Antifungal for >3 days
- •Allergy to an echinocandin
研究组 & 干预措施
Anidulafungin
Patients at risk will receive therapy with anidulafungin
干预措施: Anidulafungin (Drug)
结局指标
主要结局
Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin
时间窗: 30 days
The main interest is to evaluate the ocurrence of candidemia in patients with negative 1,3 beta-D-glucan who discontinue anidulafungin
次要结局
未报告次要终点
研究者
Marcio Nucci
MD
Universidade Federal do Rio de Janeiro