This article is part of the supplement: Severe sepsis and drotrecogin alfa (activated)

Review

Clinical trials in severe sepsis with drotrecogin alfa (activated)

Pierre-François Laterre

Department of Critical Care Medicine, St-Luc University Hospital, Université Catholique de Louvain, Avenue Hippocrate, 1200 Brussels, Belgium

author email corresponding author email

Critical Care 2007, 11(Suppl 5):S5doi:10.1186/cc6156

Published:	19 December 2007

Abstract

Drotecogin alfa (activated; DrotAA) was approved in 2001 by the US Food and Drug Administration for the treatment of patients with severe sepsis who are at high risk for death. The European Agency for the Evaluation of Medical Products also recommended that DrotAA could be administered to patients with severe sepsis and multiple organ dysfunction when added to the best standard care. Following the initial publication of the PROWESS (Protein C Worldwide Evaluation in Severe Sepsis) findings, multiple subgroup analyses supported the need for additional studies to explore the various hypotheses raised by this study. This review discusses all large clinical trials exploring the efficacy and safety of DrotAA and proposes recommendations for the use of DrotAA in severe sepsis.