Author: Beigel, John H.; Tebas, Pablo; Elie-Turenne, Marie-Carmelle; Bajwa, Ednan; Bell, Todd E.; Cairns, Charles B.; Shoham, Shmuel; Deville, Jaime G.; Feucht, Eric; Feinberg, Judith; Luke, Thomas; Raviprakash, Kanakatte; Danko, Janine; O’Neil, Dorothy; Metcalf, Julia A.; King, Karen; Burgess, Timothy H.; Aga, Evgenia; Lane, H. Clifford; Hughes, Michael D.; Davey, Richard T.
Title: A Randomized Study of Immune Plasma for the Treatment of Severe Influenza Document date: 2017_5_15
ID: 2g22oqf2_41
Snippet: For a variety of reasons, a study of this type proved to be very difficult to execute. Despite engagement of established investigators in infectious diseases, intensive care, and emergency medicine at 29 academic medical centers, enrollment and randomization of 98 participants took over 4 years. Major challenges included a low incidence of influenza illness in some years of the study and the lack of experience of most blood establishments with us.....
Document: For a variety of reasons, a study of this type proved to be very difficult to execute. Despite engagement of established investigators in infectious diseases, intensive care, and emergency medicine at 29 academic medical centers, enrollment and randomization of 98 participants took over 4 years. Major challenges included a low incidence of influenza illness in some years of the study and the lack of experience of most blood establishments with using plasma as an investigational product. Some participants, families, and even treating physicians also expressed reluctance in using a human blood product for a disease like influenza, where morbidity and mortality is often underappreciated. There were additional challenges unique to the investigational product including the moving target of antigenic drift in circulating influenza subtypes and the need to match this evolution over time with contemporaneous plasma, and the comparatively short shelf life of plasma units necessitating frequent replenishment of expiring units.
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