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Sponsors and Collaborators: |
FDA Office of Orphan Products Development IWK Health Centre |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004422 |
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 |
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Pertussis Whooping Cough |
Drug: immune globulin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Estimated Enrollment: | 174 |
Study Start Date: | 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.
Ages Eligible for Study: | up to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
- Documented infection with Bordetella pertussis
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 |
bacterial infection immunologic disorders and infectious disorders pertussis rare disease |
Bacterial Infections Antibodies Immunologic Factors Respiratory Tract Diseases Respiratory Tract Infections |
Rare Diseases Cough Whooping Cough Immunoglobulins Gram-Negative Bacterial Infections |
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 |