Status:
COMPLETED
Safety and Efficacy of Procalcitonin Guided Antibiotic Therapy in Adult Intensive Care Units (ICU's)
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
UMC Utrecht
Elisabeth-TweeSteden Ziekenhuis
Conditions:
Sepsis
Severe Sepsis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a randomized controlled trial comparing standard-of-care therapy of infections in critically ill patients with a procalcitonin-guided approach evaluating efficacy (antibiotics consumption) and...
Detailed Description
Antibiotics are prescribed widely in intensive care units and are linked with high costs and the occurence of antimicrobial (multi)resistance. The optimal duration of antibiotic treatment is poorly kn...
Eligibility Criteria
Inclusion
- Age over 18 years old
- receiving antibiotics for no more than 24 hours for an assumed or proven infection
- Informed consent
Exclusion
- Failure to obtain written consent to participate
- Patients receiving prolonged antibiotic therapies (\> 3 weeks, e.g. endocarditis, cerebral/hepatic abscess)
- Patients with severe infections due to viruses or parasites (e.g. Dengue, Toxoplasma gondii, Plasmodium spp.)
- Patients infected with Mycobacterium tuberculosis
- Patients entering the ICU for post-operative observation and/or on antibiotic prophylaxis with an estimated length of stay less then 24 hrs.
- Patients suffering from cystic fibrosis
- Severely immunocompromised patients such as patients with HIV and with a CD4 count of less than 200 cells/mm, neutropenic patients (\<500 neutrophils per mL) or patients with solid organ transplantation
- Moribund patients
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
1575 Patients enrolled
Trial Details
Trial ID
NCT01139489
Start Date
November 1 2009
End Date
August 1 2014
Last Update
January 6 2016
Active Locations (1)
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1
VU University medical center
Amsterdam, Netherlands, 1081 HV