Clinical Trial: Intravenous Pertussis Immune Globulin in Patients with Severe Childhood Pertussis Infection

This study is no longer recruiting patients.

Sponsors and Collaborators: FDA Office of Orphan Products Development
IWK Grace Health Centre
Information provided by: FDA Office of Orphan Products Development

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 Treatment or Intervention Phase
Pertussis
Whooping Cough
 Drug: immune globulin
Phase III

MedlinePlus related topics:  Bacterial Infections;   Bronchitis;   Respiratory Diseases;   Whooping Cough

Study Type: Interventional
Study Design: Treatment, Randomized

Further Study Details: 

Expected Total Enrollment:  174

Study start: August 1997

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

Criteria

  • Documented infection with Bordetella pertussis

Location Information

Study chairs or principal investigators

Scott A. Halperin,  Study Chair,  IWK Grace Health Centre   

More Information

Study ID Numbers:  199/13322; IWK-FDR001044; P9701
Record last reviewed:  June 2000
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004422
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources