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.

Condition	Treatment or Intervention
Infant Botulism Botulism	Drug: botulism immune globulin

Further Study Details: 

Expected Total Enrollment:  120

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.

Ages Eligible for Study:  up to  1 Year,  Genders Eligible for Study:  Both

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

California
      California Department of Health Services, Berkeley,  California,  94704-1011,  United States; Recruiting

Study chairs or principal investigators

Stephen S. Arnon,  Study Chair,  California Department of Health Services   

Study ID Numbers:  199/13253; CDHS-FDU000476
Record last reviewed:  March 2000
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004401
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08