Abstract
A 5-year, randomized, double-blind, placebo-controlled trial of the orphan drug Human Botulism Immune Globulin Intravenous (BIG-IV) in 122 infants in California with confirmed infant botulism (75 caused by type A Clostridium botulinum toxin, and 47 by type B toxin) was conducted at the California Department of Health Services, Richmond, CA; National Botulism Surveillance and Reference Laboratory, CDC and P, Atlanta; and Division of Biostatistics, University of California, Berkeley.
Highlights
A 5-year, randomized, double-blind, placebo-controlled trial of the orphan drug Human Botulism Immune Globulin Intravenous (BIG-IV) in 122 infants in California with confirmed infant botulism (75 caused by type A Clostridium botulinum toxin, and 47 by type B toxin) was conducted at the California Department of Health Services, Richmond, CA; National Botulism Surveillance and Reference Laboratory, CDC and P, Atlanta; and Division of Biostatistics, University of California, Berkeley
Infants treated with BIG-IV showed significant reductions in hospital stay, time in intensive care, duration of mechanical ventilation, duration of tube or intravenous feeding, and hospital charges
In a 6-year nation-wide, open-label study, infants treated with BIG-IV within 7 days of admission had a mean hospital stay of 2.2 weeks, and early treatment shortened the length of stay significantly more than later treatment
Summary
TRIAL OF IMMUNE GLOBULIN IN INFANT BOTULISM A 5-year, randomized, double-blind, placebo-controlled trial of the orphan drug Human Botulism Immune Globulin Intravenous (BIG-IV) in 122 infants in California with confirmed infant botulism (75 caused by type A Clostridium botulinum toxin, and 47 by type B toxin) was conducted at the California Department of Health Services, Richmond, CA; National Botulism Surveillance and Reference Laboratory, CDC and P, Atlanta; and Division of Biostatistics, University of California, Berkeley. Eligible infants had acute flaccid paralysis consistent with infant botulism and had been hospitalized for
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