A Controlled Clinical Trial of E5 Murine Monoclonal IgM Antibody to Endotoxin in the Treatment of Gram-Negative Sepsis
Objective.—To assess the efficacy of adjunctive monoclonal antibody antiendotoxin immunotherapy in patients with gram-negative sepsis. Design.—Double-blind, randomized, placebo-controlled trial. Setting.—Thirty-three university-affiliated centers, including Veterans Affairs, community, and municipal hospitals. Patients.—Hospitalized adults with signs of gram-negative infection and a systemic septic response. Intervention.—Patients were assigned to receive either 2 mg/kg of a murine monoclonal antibody directed against gram-negative endotoxin (E5) or placebo. A second infusion was administered 24 hours later. Main Outcome Measures.—Mortality over the 30-day study period, resolution of organ failures, and safety. Results.—Four hundred eighty-six patients were enrolled. Three hundred sixteen had confirmed gram-negative sepsis (54% bacteremic, 46% nonbacteremic). The survival difference was not statistically significant for all patients. Among patients with gram-negative sepsis who were not in shock at study entry (n = 137), E5 treatment resulted in significantly greater survival (relative risk, 2.3; P =.01). Resolution of individual organ failures was more frequent among these patients, occurring in 19 (54%) of 35 patients in the E5 group vs eight (30%) of 27 in the placebo group (P =.05). Four reversible allergic reactions occurred among 247 patients (1.6%) receiving E5. No other toxicity was identified. Conclusions.—Treatment with E5 antiendotoxin antibody appears safe. It reduces mortality and enhances the resolution of organ failure among patients with gram-negative sepsis who are not in shock when treated. © 1991, American Medical Association. All rights reserved.
Greenman, RL; Schein, RMH; Martin, MA; Wenzel, RP; Maclntyre, NR; Emmanuel, G; Chmel, H; Kohler, RB; McCarthy, M; Plouffe, J; Russell, JA
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