Journal Article

Randomized, Placebo-Controlled Trial of HA-1A, a Human Monoclonal Antibody to Endotoxin, in Children with Meningococcal Septic Shock

Bert Derkx, Janet Wittes and Richard McCloskey

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 28, issue 4, pages 770-777
Published in print April 1999 | ISSN: 1058-4838
Published online April 1999 | e-ISSN: 1537-6591 | DOI: https://dx.doi.org/10.1086/515184
Randomized, Placebo-Controlled Trial of HA-1A, a Human Monoclonal Antibody to Endotoxin, in Children with Meningococcal Septic Shock

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Meningococcal septic shock has a rapid onset and characteristic skin hemorrhages that allow bedside diagnosis. Initial plasma endotoxin levels are high and correlate closely with clinical outcome. In a double-blind, randomized, placebo-controlled trial (planned, n = 270; actual, n = 269), we compared the effectiveness of HA-1A (6 mg/kg of body weight iv; maximum, 100 mg), a human monoclonal antibody to endotoxin, and placebo in reducing the 28-day all-cause mortality rate among children with a presumptive clinical diagnosis of meningococcal septic shock. Treatment groups were well balanced for baseline characteristics and prespecified prognostic variables. In this trial no significant benefit of HA-1A could be demonstrated. The 28-day mortality rates in the intention-to-treat analysis were as follows: placebo, 28%; HA-1A, 18%; reduction in mortality, 33% (P = .11, per Fisher's exact test, two-tailed; odds ratio = 0.59; 95% confidence interval for the difference, 0.31−1.05). All patients tolerated HA-1A well, and no antibodies to HA-1A were detected.

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Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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