Severe Sepsis Clinical Trial
Official title:
De-escalation of Empirical Antimicrobial Therapy Study in Severe Sepsis: A Randomized Clinical Trial (DEA Study)
Rational: Severe sepsis is one of the leading cause of mortality in intensive care unit
patients. Early initiation of an appropriate empirical antimicrobial therapy is associated
with improved outcomes. In order to avoid an increase of selection pressure and the
emergence of multidrug resistant pathogens, guidelines recommend to streamline the
antimicrobial therapy after the identification of the pathogen responsible for infection.
This strategy has been evaluated in several observational studies. However, at the bedside,
few randomized clinical trials tested this strategy prospectively.
Method: the investigators conduct a randomized clinical trial comparing a strategy based on
de-escalation (streamlining of the empirical antimicrobial therapy) and a conservative
strategy (continuation of the empirical antimicrobial therapy). The investigators first aim
was to show that a strategy based on de-escalation is not inferior to a conservative
strategy in terms of intensive care unit length of stay. Secondary aims are to compare the
rate of mortality rate, the emergence of multidrug resistant pathogens, and the feasibility
of de-escalation. The study is performed in nine intensive care units from four
institutions, and 120 patients are required to validate the investigators hypothesis. New
technologies for the rapid diagnosis of severe infections are investigated in an ancillary
study.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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