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Previous Volume 354:462-471 February 2, 2006 Number 5 Next

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ABSTRACT

Background We created the orphan drug Human Botulism Immune Globulin Intravenous (BIG-IV), which neutralizes botulinum toxin, and evaluated its safety and efficacy in treating infant botulism, the intestinal-toxemia form of human botulism.

Methods We performed a five-year, randomized, double-blind, placebo-controlled trial statewide, in California, of BIG-IV in 122 infants with suspected (and subsequently laboratory-confirmed) infant botulism (75 caused by type A Clostridium botulinum toxin, and 47 by type B toxin); treatment was given within three days after hospital admission. We subsequently performed a 6-year nationwide, open-label study of 382 laboratory-confirmed cases of infant botulism treated within 18 days after hospital admission.

Results As compared with the control group in the randomized trial, infants treated with BIG-IV had a reduction in the mean length of the hospital stay, the primary efficacy outcome measure, from 5.7 weeks to 2.6 weeks (P<0.001). BIG-IV treatment also reduced the mean duration of intensive care by 3.2 weeks (P<0.001), the mean duration of mechanical ventilation by 2.6 weeks (P=0.01), the mean duration of tube or intravenous feeding by 6.4 weeks (P<0.001), and the mean hospital charges per patient by $88,600 (in 2004 U.S. dollars; P<0.001). There were no serious adverse events attributable to BIG-IV. In the open-label study, infants treated with BIG-IV within seven days of admission had a mean length of hospital stay of 2.2 weeks, and early treatment with BIG-IV shortened the mean length of stay significantly more than did later treatment.

Conclusions Prompt treatment of infant botulism type A or type B with BIG-IV was safe and effective in shortening the length and cost of the hospital stay and the severity of illness.

Source Information

From the Infant Botulism Treatment and Prevention Program (S.S.A., R.S.), California Department of Health Services, Richmond; the National Botulism Surveillance and Reference Laboratory, Centers for Disease Control and Prevention, Atlanta (S.E.M., C.L.H.); and the Division of Biostatistics, School of Public Health, University of California, Berkeley (N.P.J.).

Dr. Hatheway is deceased.

Address reprint requests to Dr. Arnon at the California Department of Health Services, 850 Marina Bay Pkwy., Rm. E-361, Richmond, CA 94804, or at sarnon{at}dhs.ca.gov.

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