Botulism Clinical Trial
OBJECTIVES: I. Determine the safety of human botulism immune globulin (BIG) in patients with
infant botulism by monitoring side effects (e.g., rash, fever, hypotension, and
anaphylaxis).
II. Assess the efficacy of BIG in these patients by monitoring disease severity, incidence
of complications (respiratory arrest, aspiration, pneumonia, etc.), and length of hospital
stay.
PROTOCOL OUTLINE: This is an open label, multicenter study. Patients should begin therapy
within 72 hours of hospital admission, but may receive human botulism immunoglobulin (BIG)
in certain circumstances after 72 hours. Patients receive (BIG) IV. Patients are monitored
for side effects, disease severity, complications, and length of hospital stay.
Patients are followed at 2 weeks after treatment, then every 4 weeks for 6 months.
Completion date provided represents the completion date of the grant per OOPD records
;
Masking: Open Label, Primary Purpose: Treatment
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