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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
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.
Saint Louis University - medical intensive care unit
St Louis, Missouri, United States
Cooper University Hospital
Camden, New Jersey, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Days on antibiotics beginning with day 4 until the first day without antibiotics (up to max. 28 days follow up)
Time frame: 28 days
Days on antibiotics during ICU stay
Time frame: up to 28 days
Sepsis classification
Time frame: up to 28 days
SOFA score (modified)
Time frame: up to 28 days
ICU or hospital mortality up to 28 days
Time frame: up to 28 days
Frequency of infections
Time frame: up to 28 days
ICU and hospital length of stay
Time frame: up to 28 days
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