Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection - Full Text View

Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	FDA Office of Orphan Products Development IWK Health Centre
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004422

Purpose

OBJECTIVES:

Assess the efficacy of a single infusion of a high titer pertussis immune globulin for the treatment of severe pertussis in children.

Condition	Intervention	Phase
Pertussis Whooping Cough	Drug: immune globulin	Phase III

MedlinePlus related topics:

Cough Whooping Cough

Drug Information available for:

Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	174
Study Start Date:	August 1997

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.

Eligibility

Ages Eligible for Study:	up to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Documented infection with Bordetella pertussis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004422

Sponsors and Collaborators

FDA Office of Orphan Products Development

IWK Health Centre

Investigators


Study Chair:	Scott A. Halperin	IWK Health Centre

More Information

Study ID Numbers:	199/13322, IWK-FDR001044, P9701
First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004422
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

bacterial infection

immunologic disorders and infectious disorders

pertussis

rare disease

Study placed in the following topic categories:

Bacterial Infections

Respiratory Tract Diseases

Respiratory Tract Infections

Rare Diseases

Cough

Whooping Cough

Whooping cough

Immunoglobulins

Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Bordetella Infections

Immunologic Factors

Physiological Effects of Drugs

Infection

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008