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Home > "S" Clinical Trials Conditions > Study of Human Botulism Immunoglobulin in Infants With Botulism  Study of Human Botulism Immunoglobulin in Infants With Botulism
Study of Human Botulism Immunoglobulin in Infants With Botulism
For Condition: Infant Botulism,Botulism
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development , California Department of Health Services
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: /1 Year
Genders: Both
Protocol Entry 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
Total Enrollment: 120
Location and Contact Information:
Overall Study Official:
StephenArnon, Study Chair, California Department of Health Services
California Department of Health Services *Recruiting*
Berkeley, California, 94704-1011
United States
Recruiting Stephen Arnon 510-540-2646
Additional Information:
Study ID Numbers: 199/13253; CDHS-FDU000476
Study Start Date: January 1998
Record last reviewed: March 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004401
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1. Study of Human Botulism Immunoglobulin in Infants With Botulism
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Study of Human Botulism Immunoglobulin in Infants With Botulism
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