Procalcitonin Level to Discontinue Antibiotics on ICU Patients With no Obvious Site of Infection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Infection, Bacterial Infection, Sepsis

Intervention / Treatment
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* Device: Procalcitonin assay - B.R.A.H.M.S PCT sensitive Kryptor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard treatment | |
| Experimental: PCT<br>PCT guided arm | Device: Procalcitonin assay - B.R.A.H.M.S PCT sensitive Kryptor<br>* antibiotic treatment based on clinical decision making with traditional thought processes used in both groups. In addition the physician will be given access to Procalcitonin values with recommended thresholds for likelihood of infection.<br>* Other names: B.R.A.H.M.S, Kryptor, Procalcitonin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days on antibiotics beginning with day 4 until the first day without antibiotics (up to max. 28 days follow up) |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bacterial infection, empiric antibiotic treatment, duration antibiotic treatment, reduce antibiotic treatment, procalcitonin, PCT Kryptor, sepsis, Intensive Care Unit, antibiotic treatment