Sepsis Clinical Trial
Official title:
A Randomized Prospective Clinical Trial to Assess the Role of Procalcitonin-guided Antimicrobial Therapy to Reduce Long-term Infections Sequelae
The aim of the study is to demonstrate if using one procalcitonin (PCT)-guided rule of stop of antimicrobials, the incidence of infections by C.difficile and by Multi-Drug-Resistant (MDR) bacteria during the next six months may be significantly decreased.
Early administration of antimicrobials remains the mainstay of treatment of severe
infections. Current guidelines of management of severe sepsis suggest that initial therapy of
a patient should be reviewed after 48 to 72 hours. At that stage some patients are doing
well, whereas others fail to respond. When microbiology cultures of biological specimens fail
to provide information for the microbial cause of an infection and susceptibilities to
antimicrobials, antimicrobial stewardship relies on the use of biomarkers and mainly
procalcitonin (PCT). Data so far, suggest that early changes of serum PCT can inform about
the prognosis of the septic patient, with greater values reflecting a worse outcome and
higher mortality and that serial measurements within 48-72 hours provide adequate information
of the appropriateness of the administered antimicrobials. Moreover the use of a
procalcitonin guided-treatment in surgical as well as in non-surgical critically-ill
patients, is seen to be non-inferior to the standard antibiotic approach and leads to a
shorter antibiotic exposure, having possible beneficial effect on reducing microbial
resistance and therapy costs.
In the largest study conducted so far, de Jong et al showed that PCT-guided stop of treatment
was not only safe compared with standard of care antibiotic duration, but also led to a
better outcome i.e. significant decrease of both 28-day and 1-year mortality. The results of
this study are a major contribution in the field of critical care since they prove for the
first time that PCT guidance of antimicrobial treatment allows not only proper antimicrobial
stewardship but it is also associated with survival benefit. However, de Jong et al did not
provide findings to explain the underlying mechanism of survival benefit. As a rule
critically ill patients run two major risks coming from the long-term administration of
antimicrobials; the first is infections by Clostridium difficile coming from the ecological
damage of gut flora and the second is the risk of infections by multidrug-resistant (MDR)
bacteria colonizing the gut. MDR is emerging after the ecological pressure of broad-spectrum
antimicrobial usually administered to the critically ill patient.
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