Status:
TERMINATED
Procalcitonin Level to Discontinue Antibiotics on ICU Patients With no Obvious Site of Infection
Lead Sponsor:
Brahms AG
Conditions:
Infection
Bacterial Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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 rand...
Eligibility Criteria
Inclusion
- 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
- 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- Patient withdrawn from empiric antibiotic treatment before Day 4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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00407147
Start Date
July 1 2008
End Date
June 1 2009
Last Update
January 18 2012
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Saint Louis University - medical intensive care unit
St Louis, Missouri, United States, 63110
2
Cooper University Hospital
Camden, New Jersey, United States, 08103
3
Rhode Island Hospital
Providence, Rhode Island, United States, 02903