Study of Human Botulism Immunoglobulin in Infants With Botulism
Keywords
Abstract
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
Dates
| Last Verified: | 02/29/2000 |
| First Submitted: | 10/17/1999 |
| Estimated Enrollment Submitted: | 10/17/1999 |
| First Posted: | 10/18/1999 |
| Last Update Submitted: | 03/23/2015 |
| Last Update Posted: | 03/24/2015 |
| Actual Study Start Date: | 12/31/1997 |
| Estimated Study Completion Date: | 05/31/1998 |
Condition or disease
Intervention/treatment
Drug: botulism immune globulin
Phase
Eligibility Criteria
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
