Study of Human Botulism Immunoglobulin in Infants With Botulism

• Status: Completed
• Trial end date: 1998-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: California Department of Health Services
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

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