Introduction of new technology into critical care practice : a history of HA-1A human monoclonal antibody against endotoxin.
HA-1A a monoclonal antibody against endotoxin, was thought to be effective in treating patients with Gram-negative sepsis.
Because of this possibility, many clinicians felt obligated to use the drug and assumed that its product license application would be approved by the U.S. Food and Drug Administration (FDA).
Nevertheless, the efficacy of HA-1A was not conclusively demonstrated by a first clinical trial.
The FDA rejected the product license application and requested a second clinical trial, which was suspended after excess mortality Was noted in patients treated with HA-1A.
This review of the history of the drug was prepared to provide clinicians and sepsis investigators with information about HA-1A and, by extension, the process by which new technology is introduced into critical care practice.
Mots-clés Pascal : Choc, Traitement, Bactériose, Infection, Bactérie Gram négatif, Economie santé, Soin intensif, Anticorps monoclonal, Article synthèse, Immunothérapie, Analyse coût, Etats Unis, Amérique du Nord, Amérique, Endotoxine, Homme
Mots-clés Pascal anglais : Shock, Treatment, Bacteriosis, Infection, Gram negative bacteria, Health economy, Intensive care, Monoclonal antibody, Review, Immunotherapy, Cost analysis, United States, North America, America, Endotoxin, Human
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 93-0600295
Code Inist : 002B27B10. Création : 199406.