ProBac - Use of Procalcitonin Level as Part of a Decision Tree to Discontinue Antibiotics When Started Empirically in the ICU in Hemodynamically Stable Patients With no Site of Infection Identified
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 6
- 主要终点
- Days on antibiotics beginning with day 4 until the first day without antibiotics (up to max. 28 days follow up)
研究概览
简要总结
The purpose of this study is to test whether a U.S. Food and Drug Administration (FDA) approved laboratory test (PCT Kryptor) can help doctors make better decisions on the need for antibiotic therapy in ICU patients with suspected infections.
详细描述
The study is undertaken as prospective, randomized, controlled, multicenter trial. The study population, ICU patients with empiric antibiotic treatment due to suspected but unproven infection, is randomly assigned to either a Standard Care Group or a Procalcitonin (PCT) Guided Group. In the standard care group, antibiotic treatment would be based totally on clinical decision making with "traditional thought processes" (i.e., cultures, response to antibiotics, risk of untreated infection, other laboratory findings, etc.). The PCT guided group will use the same "traditional thought processes" and in addition the physician will be given access to a PCT value for Day 1 and Day 4 along with the recommended thresholds for likelihood of infection. In conjunction with other laboratory findings and clinical assessments the threshold of PCT is used to continue or discontinue empiric antibiotic treatment.
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
- •Suspected infection (no clear-cut source of infection) as defined by the treating physician
- •Empiric antibiotic treatment
- •No clear-cut source of infection by clinical or microbiological criteria
- •ICU patient
- •Informed consent
排除标准
- •Age <18 years
- •Pregnancy
- •Hemodynamic instability defined as persistent hypotension, need for on-going aggressive resuscitation and/or vasopressor support to maintain an adequate mean arterial blood pressure
- •Need for antibiotic prophylaxis
- •Patient withdrawn from empiric antibiotic treatment before Day 4
- •Severely immuno-compromised patient (liver cirrhosis (Child-Pugh class C), immunosuppressive drugs after transplantation, neutropenia (absolute neutrophil count <1000 counts/L), CD-4 count less than 200)
- •Patient with suspected bacterial or fungal endocarditis
- •Patient with suspected meningitis
- •Cardiopulmonary bypass within the last 7 days1)
- •Major surgery within the last 7 days (surgery that induces a major inflammatory response such as heart or aortic surgery or major abdominal surgery (i.e. duodenopancreatectomy) or any surgery requiring massive blood transfusion.)
- •Multiple trauma within the last 7 days
- •Cardiopulmonary resuscitation (CPR) within the last 7 days
- •Burns >20% body surface area
- •Patient in terminal status referred for palliative care
- •Patient with advanced directives or Do Not Resuscitate (DNR) orders
- •Patient who is already enrolled in another therapeutic clinical study
结局指标
主要结局
Days on antibiotics beginning with day 4 until the first day without antibiotics (up to max. 28 days follow up)
时间窗: 28 days
次要结局
- Days on antibiotics during ICU stay(up to 28 days)
- Sepsis classification(up to 28 days)
- SOFA score (modified)(up to 28 days)
- ICU or hospital mortality up to 28 days(up to 28 days)
- Frequency of infections(up to 28 days)
- ICU and hospital length of stay(up to 28 days)