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| Tracking Information | |||||
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| First Received Date ICMJE | October 18, 1999 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | August 1997 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00004422 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection | ||||
| Official Title ICMJE | |||||
| 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. |
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| 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. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: immune globulin | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 174 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | - Documented infection with Bordetella pertussis |
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| Gender | Both | ||||
| Ages | up to 5 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00004422 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 199/13322, IWK-FDR001044, P9701 | ||||
| Study Sponsor ICMJE | FDA Office of Orphan Products Development | ||||
| Collaborators ICMJE | IWK Health Centre | ||||
| Investigators ICMJE |
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| Information Provided By | FDA Office of Orphan Products Development | ||||
| Verification Date | June 2000 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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