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Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00004422
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
Sponsor:
Information provided by:
FDA Office of Orphan Products Development

Brief Summary:

OBJECTIVES:

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


Condition or disease Intervention/treatment Phase
Pertussis Whooping Cough Drug: immune globulin Phase 3

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


Study Type : Interventional  (Clinical Trial)
Enrollment : 174 participants
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : August 1997
Study Completion Date : September 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Whooping Cough
Drug Information available for: Rhophylac
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Documented infection with Bordetella pertussis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004422


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

ClinicalTrials.gov Identifier: NCT00004422     History of Changes
Other Study ID Numbers: 199/13322
IWK-FDR001044
P9701
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: June 2000

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