Botulism, Infant Botulism
Conditions
Keywords
bacterial infection, clostridium infection, immunologic disorders and infectious disorders, infant botulism, rare disease
Brief summary
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.
Detailed description
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
Interventions
DRUGbotulism immune globulin
Sponsors
California Department of Health Services
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
No
Inclusion criteria
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
Countries
United States
Outcome results
None listed