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May 6, 1992

Antibody to Endotoxin in the Treatment of Gram-negative Sepsis

Author Affiliations

Academic Medical Center Amsterdam, the Netherlands

JAMA. 1992;267(17):2325-2326. doi:10.1001/jama.1992.03480170051016

To the Editor.  —Greenman et al1 reported a clinical trial with the murine antiendotoxin antibody E5 and concluded that this treatment reduces mortality and enhances the resolution of organ failure in patients with gram-negative sepsis who are not in shock at the time of treatment.I do not agree that these conclusions are substantiated by the data presented. First, nowhere in the article is the main end point of this trial, as prospectively defined in an analytic plan, mentioned. Having been involved in several therapeutic clinical trials on patients with sepsis, it seems highly unlikely that one would prospectively define a group of patients characterized by organ failure but without shock as the group that would benefit most from antiendotoxin treatment. In fact, most patients with adult respiratory distress syndrome or renal failure have experienced a period of hypotension from which they may or may not be successfully resuscitated,