NCT00004401

Study of Human Botulism Immunoglobulin in Infants With Botulism

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: California Department of Health Services · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Infant Botulism
• Botulism

Interventions

Type	Name	Description
DRUG	botulism immune globulin

Timeline

• Start date: 1998-01-01
• Completion: 1998-06-01
• First posted: 1999-10-19
• Last updated: 2015-03-25

Locations

1 site across 1 country: United States