Treatment of gram-negative septic shock with human IgG antibody to Escherichia coli J5: a prospective, double-blind, randomized trial.
In a randomized, double-blind, multicenter trial we compared the efficacy of a preparation of human IgG antibody to Escherichia coli J5 (J5-IVIG) with that of a standard IgG preparation (IVIG) for the treatment of gram-negative septic shock. At study entry, patients received a single intravenous dose of 200 mg/kg of body weight (maximal dose, 12 g) of either J5-IVIG or IVIG. Of the 100 patients randomized, 71 (30 receiving J5-IVIG and 41 receiving IVIG) had a documented gram-negative infection. Mortality from gram-negative septic shock was 50% (15 of 30) in J5-IVIG recipients and 49% (20 of 41) in IVIG recipients. In addition, treatment with J5-IVIG did not reduce the number of systemic complications of shock and did not delay the occurrence of death due to septic shock. Thus we conclude that J5-IVIG was not superior to IVIG in reducing mortality or in reversing gram-negative septic shock.
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004926:Escherichia coli / Q000276:immunology*; D005260:Female; D006090:Gram-Negative Bacteria; D006801:Humans; D007116:Immunization, Passive; D007074:Immunoglobulin G / Q000276:immunology / Q000627:therapeutic use*; D016756:Immunoglobulins, Intravenous; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011897:Random Allocation; D018805:Sepsis / Q000150:complications / Q000628:therapy; D012772:Shock, Septic / Q000150:complications / Q000401:mortality / Q000628:therapy*
D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous