Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection

This study has been completed.
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004422
First received: October 18, 1999
Last updated: March 24, 2015
Last verified: June 2000
  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:


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

Estimated Enrollment: 174
Study Start Date: August 1997
Estimated Study Completion Date: September 2002
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.

Completion date provided represents the completion date of the grant per OOPD records

  Eligibility

Ages Eligible for Study:   up to 5 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Documented infection with Bordetella pertussis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
IWK Health Centre
Investigators
Study Chair: Scott A. Halperin IWK Health Centre
  More Information

ClinicalTrials.gov Identifier: NCT00004422     History of Changes
Other Study ID Numbers: 199/13322  IWK-FDR001044  P9701 
Study First Received: October 18, 1999
Last Updated: March 24, 2015
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
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016