Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004422
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection
Sponsor:
IWK Health Centre
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-06
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
Assess the efficacy of a single infusion of a high titer pertussis immune globulin for the treatment of severe pertussis in children
Assess the efficacy of a single infusion of a high titer pertussis immune globulin for the treatment of severe pertussis in children
Detailed Description:
PROTOCOL OUTLINE This is a randomized multicenter study Patients are randomized to receive an infusion of either pertussis immune globulin or placebo 09 saline
Patients are followed every 2 weeks for up to 6 months
Completion date provided represents the completion date of the grant per OOPD records
Patients are followed every 2 weeks for up to 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 |
|---|---|---|---|
| P9701 | None | None | None |
| IWK-FDR001044 | None | None | None |