Study of Human Botulism Immunoglobulin in Infants With Botulism
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 Design:||Masking: None (Open Label)
Primary Purpose: Treatment
|Study Start Date:||January 1998|
|Estimated Study Completion Date:||June 1998|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004401
|United States, California|
|California Department of Health Services|
|Berkeley, California, United States, 94704-1011|
|Study Chair:||Stephen S. Arnon||California Department of Health Services|