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Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2000 by FDA Office of Orphan Products Development.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
IWK Health Centre
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004422
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: June 2000
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:

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

ClinicalTrials.gov Identifier: NCT00004422     History of Changes
Other Study ID Numbers: 199/13322, IWK-FDR001044, P9701
Study First Received: October 18, 1999
Last Updated: June 23, 2005
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:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
 Respiratory Tract Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013