Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection
Primary Purpose
Pertussis, Whooping Cough
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
immune globulin
Sponsored by
About this trial
This is an interventional treatment trial for Pertussis focused on measuring bacterial infection, immunologic disorders and infectious disorders, pertussis, rare disease
Eligibility Criteria
Documented infection with Bordetella pertussis
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00004422
Brief Title
Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection
Study Type
Interventional
2. Study Status
Record Verification Date
June 2000
Overall Recruitment Status
Completed
Study Start Date
August 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
IWK Health Centre
4. Oversight
5. Study Description
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.
Detailed Description
PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive an infusion of either pertussis immune globulin or placebo (0.9% 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pertussis, Whooping Cough
Keywords
bacterial infection, immunologic disorders and infectious disorders, pertussis, rare disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
174 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
immune globulin
10. Eligibility
Sex
All
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Documented infection with Bordetella pertussis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott A. Halperin
Organizational Affiliation
IWK Health Centre
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection
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