• R L Greenman, R M Schein, M A Martin, R P Wenzel, N R MacIntyre, G Emmanuel, H Chmel, R B Kohler, M McCarthy, and J Plouffe.
• Department of Medicine, Miami (Fla) Veterans Affairs Medical Center.
• JAMA. 1991 Aug 28; 266 (8): 1097-102.

ObjectiveTo assess the efficacy of adjunctive monoclonal antibody antiendotoxin immunotherapy in patients with gram-negative sepsis.DesignDouble-blind, randomized, placebo-controlled trial.SettingThirty-three university-affiliated centers, including Veterans Affairs, community, and municipal hospitals.PatientsHospitalized adults with signs of gram-negative infection and a systemic septic response.InterventionPatients 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 MeasuresMortality over the 30-day study period, resolution of organ failures, and safety.ResultsFour 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.ConclusionsTreatment 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.

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