Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection

NCT ID: NCT00004422

Last Updated: 2015-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-08-31

Study Completion Date

2002-09-30

Brief Summary

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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

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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

Conditions

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Pertussis Whooping Cough

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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immune globulin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Documented infection with Bordetella pertussis
Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IWK Health Centre

OTHER

Sponsor Role lead

Principal Investigators

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Scott A. Halperin

Role: STUDY_CHAIR

IWK Health Centre

Other Identifiers

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IWK-FDR001044

Identifier Type: -

Identifier Source: secondary_id

P9701

Identifier Type: -

Identifier Source: secondary_id

199/13322

Identifier Type: -

Identifier Source: org_study_id

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