Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004401
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Study of Human Botulism Immunoglobulin in Infants With Botulism
Sponsor:
California Department of Health Services
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Determine the safety of human botulism immune globulin BIG in patients with infant botulism by monitoring side effects eg 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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDHS-FDU000476 | None | None | None |