Expired Study
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Berkeley, California 94704


Purpose:

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.


Study summary:

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


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


NCT ID:

NCT00004401


Primary Contact:

Study Chair
Stephen S. Arnon
California Department of Health Services


Backup Contact:

N/A


Location Contact:

Berkeley, California 94704
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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