6/29/23, 1:45 AM PROWESS Pathway Feedback Search Clinical Topics Home Studies PROWESS PROWESS Disease Sepsis and septic shock Trial question What is the role of drotrecogin alfa activated therapy in patients with systemic inflammation and organ failure due to acute infection? Study design Multi-center Double blinded RCT Population Characteristics of study participants 43.0% female N = 1690 57.0% male 1690 patients (726 female, 964 male) Inclusion criteria: patients with systemic inflammation and organ failure due to acute infection Key exclusion criteria: pregnancy or breast feeding, age < 18 years, weight > 135 kg, known hypercoagulable condition, moribund state, HIV infection, history of bone marrow, lung, liver, pancreas, or small-bowel transplantation Interventions N=850 drotrecogin alfa activated (24 g/kg of body weight per hour for a total duration of 96 hours) N=840 placebo (0.9% saline with or without 0.1% human serum albumin for a total of 96 hours) https://web.pathway.md/studies/recKGR8whmarlr4FD 1/2 6/29/23, 1:45 AM PROWESS Pathway Primary outcome Death 30.8 % 30.8 24.7 23.1 % 15.4 % Significant decrease 7.7 % NNT = 16 0.0 % Drotrecogin alfa activated Placebo Significant decrease in death (24.7% vs. 30.8%; RR 0.8, 95% CI 0.69 to 0.94) Secondary outcomes Significant decrease in risk of death, among patients with protein C deficiency (25.7% vs. 32.1%; RR 0.8, 95% CI 0.68 to 0.95) Safety outcomes No significant difference in at least one serious adverse event. Significant differences in serious bleeding (3.5% vs. 2.0%, p = 0.06). Conclusion In patients with systemic inflammation and organ failure due to acute infection, drotrecogin alfa activated was superior to placebo with respect to death. Reference Bernard GR, Vincent JL, Laterre PF et al. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med. 2001 Mar 8;344(10):699-709. Open reference URL https://web.pathway.md/studies/recKGR8whmarlr4FD 2/2