Enterobacteriaceae Infections Clinical Trial
Official title:
Randomized, Multicenter, Phase III, Controlled Clinical Trial, to Demonstrate the no Inferiority of Reduced Antibiotic Treatment vs a Broad Spectrum Betalactam Antipseudomonal Treatment in Patients With Bacteremia by Enterobacteriaceae
The continuous increase in the bacterial resistance rate and the slow arrival of new
therapeutic options have turned into an antibiotic crisis. One of the strategies proposed by
stewardship programs to try to change this situation described worldwide is the use of
antibiotics with the lowest possible antimicrobial spectrum.
Enterobacteriaceae bacteremia is a good example of how this strategy would be applied. The
empirical treatment of nosocomial bacteremia by Enterobacteriaceae comprises in several cases
one or two antibiotics with antipseudomonal activity, being much less common than desirable a
subsequent change to narrower spectrum antibiotics based on susceptibility data ("de
escalation"). This is because the safety of de escalation is based only on expert advice and
some observational studies, so their efficacy and safety is questioned by many clinicians and
therefore its use is lower than desired. In fact, a recent systematic review of the Cochrane
Library concluded that randomized studies to support this practice are needed. Investigators
propose a "real clinical practice-based" randomized trial to compare the efficacy and safety
of continuing with an antipseudomonal agents vs. de-escalation according to a pre-specified
rule, in patients with bacteraemia due to Enterobacteriaceae.
n/a
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