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A Controlled Clinical Trial of E5 Murine Monoclonal IgM Antibody to Endotoxin in the Treatment of Gram-Negative Sepsis

Richard L. Greenman, MD; Roland M. H. Schein, MD; Michael A. Martin, MD; Richard P. Wenzel, MSc, MD; Neil R. Maclntyre, MD; George Emmanuel, MD; Herman Chmel, MD; Richard B. Kohler, MD; Mary McCarthy, MD; Joseph Plouffe, MD; Jane A. Russell, RN; Elena Hollender, MD; Richard Immerman, MD; Michael Pfaller, MD; Carol Sheetz, RN; Peter Jebson, MD; Alison Houston, MT, ASCP; Dawn Rehak, RN; Patricia Empson, RN; Jill Ireland, RRT; Shakti Narain, MD; Jack E. Rashkin, MD; Richard A. Jacobs, MD; Jacqueline Octavio, RN; Rebecca Coleman, PharmD; Vicki S. Kenyon, RN; Bienvenido G. Yangco, MD; John F. Toney, MD; John Edwards, MD; Mark Crislip, MD; Ronald W. Quenzer, MD; Gordon M. Trenholme, MD; Barbara A. Schmitt, RN; Jeffrey E. Grossman, MD; Charles L. Daley, MD; Henry F. Chambers, MD; Paul B. Iannini, MD; Thomas Graziano, MD; Ronald Dandurand, MD; Gary Schieiter, MD; Mark Kunkel, MD; George A. Pankey, MD; Brenda Mayeur, RN; Sandra Abadie-Kemmerly, MD; James Zachery, MD; Michael Meadors, MD; Jeffrey Coco, MD; Charles V. Sanders, MD; W. Lance George, MD; Steven Gardner, MD; Sydney Finegold, MD; Gordon R. Bernard, MD; Paul Bogden, MD; Erlaine Bello, MD; A. Gray Ellrodt, MD; Jan Dauer, MD; Mary S. Riedinger, RN; Burt R. Meyers, MD; Thomas Iberti, MD; J. Peter Rissing, MD; Donald Nelson, MD; Quyen Luu, MD; G. Douglas Campbell, MD; Keith Olsen, PharmD; Alex Carvalho, MD; Arthur E. Brown, MD; Heinz J. Schmitt, MD; Sheldon Brown, MD; Jerome J. Schentag, PharmD; Philip B. Wels, MD; Patricia E. Wing, RN; Lynda S. Welage, PharmD; Richard Quintiliani, MD; P. H. Chandrasekar, MD; Kenneth R. Ratzan, MD; David L. Dunn, MD, PhD; Kenneth Gorelick, MD; Nancy Wedel, MD; Samuel Saks, MD; John Hannigan, MS; Samuel K. Ackerman, MD; Patrick J. Scannon, MD, PhD; David Salsburg, PhD; C. Douglas Webb, PhD
JAMA. 1991;266(8):1097-1102. doi:10.1001/jama.1991.03470080067031.
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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.(JAMA. 1991;266:1097-1102)


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