Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection

This study is ongoing, but not recruiting participants.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Collaborator:	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

Study Type:	Interventional
Study Design:	Treatment, Randomized

Resource links provided by NLM:

MedlinePlus related topics: Cough Whooping Cough

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	199/13322, IWK-FDR001044, P9701
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004422 History of Changes
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

Additional relevant MeSH terms:

Bacterial Infections
Bordetella Infections
Antibodies
Immunologic Factors
Respiratory Tract Diseases
Respiratory Tract Infections

Physiological Effects of Drugs
Whooping Cough
Infection
Pharmacologic Actions
Immunoglobulins
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on November 09, 2009