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.
Status | Completed |
Enrollment | 120 |
Est. completion date | June 1998 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 1 Year |
Eligibility |
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Clinical diagnosis of infant botulism in previously healthy infant - Bulbar palsies - Constipated Lethargy - Diminished head control - Poor feeding - Generalized weakness and hypotonia - Weak cry - Afebrile (unless secondary infection present) - Subacute to acute onset - Normal electrolytes - Any patient eligible provided no treatment available for life-threatening condition |
Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | California Department of Health Services | Berkeley | California |
Lead Sponsor | Collaborator |
---|---|
California Department of Health Services |
United States,
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