Sepsis Clinical Trial
Official title:
Stop Antibiotics on Procalcitonin Guidance Study
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 safety (mortality).
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 known and often based on consensus guidelines.
SAPS is a multicenter, prospective, randomized, controlled open-label trial evaluating the
equivalence/efficacy and safety of procalcitonin-guided treatment of infections in ICU
patients versus a standard-of-care approach.
All patients that are admitted to the ICU and for whom systemic antibiotics are prescribed
for presumed or proven bacterial infections are eligible for this trial. Patients will be
randomized and stratified according to clinical diagnosis of severe sepsis and septic shock.
Any patient over the age of 18, admitted to the ICU and receiving antibiotics for an assumed
infection can be enrolled into this trial. Informed consent has to be obtained in writing
from the patient of his/her relatives prior to inclusion. In the intervention group daily
procalcitonin levels be performed and will generate a non-binding stopping advice when
predefined stopping-rules have been reached. The ultimate decision to stop antibiotics will
be at the discretion of the physician in both groups.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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