- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004422
Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection
OBJECTIVES:
Assess the efficacy of a single infusion of a high titer pertussis immune globulin for the treatment of severe pertussis in children.
Study Overview
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
Enrollment
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- Documented infection with Bordetella pertussis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Scott A. Halperin, IWK Health Centre
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Bordetella Infections
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Whooping Cough
- Physiological Effects of Drugs
- Immunologic Factors
- Antibodies
- Immunoglobulins
- Immunoglobulins, Intravenous
- gamma-Globulins
- Rho(D) Immune Globulin
Other Study ID Numbers
- 199/13322
- IWK-FDR001044
- P9701
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pertussis
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National Institute of Allergy and Infectious Diseases...CompletedPertussis | Pertussis ImmunisationUnited States
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Sanofi Pasteur, a Sanofi CompanyCompletedPertussis (Whooping Cough)France
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Institut PasteurHopital Universitaire Robert-Debre; Hospices Civils de Lyon; Centre Hospitalier... and other collaboratorsNot yet recruitingBordetella Pertussis, Whooping CoughFrance
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Institut PasteurAgence de Médecine Préventive, France; Institut Pasteur de Madagascar; Institut...CompletedBordetella Pertussis, Whooping CoughCambodia, Madagascar, Togo
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Institut PasteurSanofi Pasteur, a Sanofi Company; Institut Pasteur of Cote d'IvoireCompletedBordetella Pertussis, Whooping CoughCôte D'Ivoire
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GlaxoSmithKlineCompletedPertussis | Pertussis VaccinesHungary
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University of SouthamptonRecruitingPertussis/Whooping CoughUnited Kingdom
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Association Clinique Thérapeutique Infantile du...Sanofi; GlaxoSmithKline; Merck Sharp & Dohme LLCRecruitingChildren, Only | Ambulatory | Pertussis/Whooping CoughFrance
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