Bacterial Infection, Infection, Sepsis
Conditions
Keywords
bacterial infection, empiric antibiotic treatment, duration antibiotic treatment, reduce antibiotic treatment, procalcitonin, PCT Kryptor, sepsis, Intensive Care Unit, antibiotic treatment
Brief summary
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
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.
Interventions
DEVICEProcalcitonin assay - B.R.A.H.M.S PCT sensitive Kryptor
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.
Sponsors
Brahms AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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vasopressor support to maintain an adequate mean arterial blood pressure * Need for antibiotic prophylaxis * Patient withdrawn from empiric antibiotic treatment before Day 4 * Severely immuno-compromised patient (liver cirrhosis (Child-Pugh class C), immunosuppressive drugs after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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Sepsis classification | up to 28 days |
| SOFA score (modified) | up to 28 days |
| Days on antibiotics during ICU stay | up to 28 days |
| Frequency of infections | up to 28 days |
| ICU and hospital length of stay | up to 28 days |
| ICU or hospital mortality up to 28 days | up to 28 days |
Countries
United States
Outcome results
None listed