termination due to futility (very slow patient enrollment)

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.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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• Patient withdrawn from empiric antibiotic treatment before Day 4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