Study of Human Botulism Immunoglobulin in Infants With Botulism

California Department of Health Services

Status: Completed

Conditions: Infant Botulism; Botulism

Treatments: Drug: botulism immune globulin

Study type: Interventional

Funder types: Other

Identifiers

NCT00004401

199/13253

CDHS-FDU000476

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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