Influence of an anti-tumor necrosis factor monoclonal antibody on cytokine levels in patients with sepsis

Objectives: To determine the safety, pharmacokinetics, and activity of an anti-tumor necrosis factor (TNF)-α monoclonal antibody in severe sepsis. Design: Open-label, prospective, phase II multicenter trial with escalating doses of a murine monoclonal antibody (CB0006). Setting: Twelve academic medical center intensive care units in the United States and Europe. Patients: Eighty patients with severe sepsis or septic shock who received standard supportive care and antimicrobial therapy in addition to the anti-TNF antibody