New Treatment for Infant Botulism

New Treatment for Infant Botulism

A human-derived botulism antitoxin (BIG-IV) is safe and effective for treatment of infant botulism.

About 100 infants develop botulism in the U.S. annually. Most infants are hospitalized for 4 to 6 weeks, and many require mechanical ventilation. Investigators from California and the CDC developed and tested a human-derived botulism antitoxin in 122 infants (age range, 21 to 313 days) with laboratory-confirmed infant botulism. BIG-IV (Human Botulism Immune Globulin Intravenous) is derived from adults who were vaccinated with pentavalent botulinum toxoid.

Infants were randomized to receive BIG-IV or placebo within 3 days of hospital admission. Compared with the placebo group, infants who received BIG-IV had significantly shorter hospitalizations (mean, 5.7 vs. 2.6 weeks), and shorter duration of intensive care (5.0 vs. 1.8 weeks), mechanical ventilation (4.4 vs. 1.8 weeks), and tube or intravenous feeding (10.6 vs. 3.6 weeks). Both type and frequency of adverse events were similar in the two groups. In an open-label study of 382 infants in 37 states, BIG-IV treatment within 3 days of admission significantly shortened mean length of hospital stay, compared with treatment within 4 to 7 days of admission (2.0 vs. 2.9 weeks).

Comment: These results are enormously gratifying. Clinicians must consider the diagnosis of botulism in any infant who presents with unexplained flaccid paralysis, hypotonia, ptosis, and weak cry or suck in the first 6 months of life.

— Howard Bauchner, MD

Published in Journal Watch Pediatrics and Adolescent Medicine February 24, 2006