Procalcitonin Level to Discontinue Antibiotics on ICU Patients With no Obvious Site of Infection (NCT00407147) | Clinical Trial Compass
TerminatedPhase 4
Procalcitonin Level to Discontinue Antibiotics on ICU Patients With no Obvious Site of Infection
Stopped: termination due to futility (very slow patient enrollment)
United States11 participantsStarted 2008-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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* Patient withdrawn from empiric antibiotic treatment before Day 4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…
What they're measuring
1
Days on antibiotics beginning with day 4 until the first day without antibiotics (up to max. 28 days follow up)