Procalcitonin Level to Discontinue Antibiotics on ICU Patients With no Obvious Site of Infection
Stopped early · Phase 4
Conditions studied: Infection, Bacterial Infection, Sepsis
In brief
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.
Key facts
- Study ID
- NCT00407147
- Run by
- Brahms AG
- People needed
- 11
- Starts
- 2008-07-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2012-01-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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- Patient withdrawn from empiric antibiotic treatment before Day 4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
Where it is running
- 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
Full record on ClinicalTrials.gov
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