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. 2022 Sep 12;10(9):2260. doi: 10.3390/biomedicines10092260

Table 2.

Future evolution of “sepsis” trials.

The Past The Future
Preclinical studies
Limited data from previously
healthy animals made septic (e.g., CLP)
Limited information on the
pathophysiologic processes
Larger variety of animal studies
Better definition of the pathway of interest
More information on the pathophysiologic processes
Development of suitable biomarkers
Clinical studies
Patient selection
Severe infection
with some degree of organ failure
Patient selection
Based on the pathophysiologic process (ideally guided by a biomarker)
Infection may not be required
Treatment dose and duration
Arbitrarily defined
Treatment dose and duration
Individualized (ideally guided by the biomarker)
Primary end-point
28-day mortality
Primary end-point
Morbidity (and mortality)

CLP = cecal ligation and puncture.