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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
IWK Health Centre
About
Eligibility
Locations
Outcomes
Full info

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

undefined - 5 Years (Child)All SexesDoes not accept healthy volunteers

Documented infection with Bordetella pertussis

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 18, 1999
    Last Updated
    March 24, 2015
    Sponsor
    IWK Health Centre
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    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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