An interventional study of botulism immune globulin in Infant Botulism and Botulism, sponsored by California Department of Health Services. Completed at 1 site in United States. Open to participants aged Up to 1 Year. Per ClinicalTrials.gov, last updated 2015-03-25.
Sponsored by California Department of Health Services · Not applicable, Interventional, and Treatment
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.
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
20 studies on the registry are indexed under Botulism; 3 are open to participants now.
This study's planned enrollment of 120 is above the median of 29 across 14 interventional studies indexed under Botulism.
Browse Botulism studies →This is the only study on the registry with California Department of Health Services as lead sponsor.
Counted across the registry records on this site, refreshed daily.
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
This study is completed, as verified in Mar 2000. You cannot join it, but the record below documents what was studied.
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