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Drotrecogin alfa, a recombinant form of protein C, reduces mortality in certain subgroups of adults with severe sepsis, but its efficacy and safety in children have not been established. In a multisite, industry-supported clinical trial, 477 children (age range, 38 weeks gestational age to 17 years) with severe sepsis (suspected or proven infection with respiratory and cardiovascular dysfunction) were randomized to receive either drotrecogin alfa or placebo for 96 hours. In 2005, the FDA and manufacturer stopped the trial because of concern about excess intracranial bleeding in the treatment group (see JWPAM Jun 13 2005). Now, the results of the interim analysis have been published.
No differences between the two groups were found in the pri…