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Sponsors and Collaborators: |
FDA Office of Orphan Products Development California Department of Health Services |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004401 |
OBJECTIVES: I. Determine the safety of human botulism immune globulin (BIG) in patients with infant botulism by monitoring side effects (e.g., rash, fever, hypotension, and anaphylaxis).
II. Assess the efficacy of BIG in these patients by monitoring disease severity, incidence of complications (respiratory arrest, aspiration, pneumonia, etc.), and length of hospital stay.
Condition | Intervention |
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Infant Botulism Botulism |
Drug: botulism immune globulin |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Estimated Enrollment: | 120 |
Study Start Date: | January 1998 |
PROTOCOL OUTLINE: This is an open label, multicenter study. Patients should begin therapy within 72 hours of hospital admission, but may receive human botulism immunoglobulin (BIG) in certain circumstances after 72 hours. Patients receive (BIG) IV. Patients are monitored for side effects, disease severity, complications, and length of hospital stay.
Patients are followed at 2 weeks after treatment, then every 4 weeks for 6 months.
Ages Eligible for Study: | up to 1 Year |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
United States, California | |
California Department of Health Services | Recruiting |
Berkeley, California, United States, 94704-1011 | |
Contact: Stephen S. Arnon 510-540-2646 |
Study Chair: | Stephen S. Arnon | California Department of Health Services |
Study ID Numbers: | 199/13253, CDHS-FDU000476 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004401 |
Health Authority: | United States: Federal Government |
bacterial infection clostridium infection immunologic disorders and infectious disorders infant botulism rare disease |
Bacterial Infections Antibodies Gram-Positive Bacterial Infections Neurotoxicity Syndromes Neuromuscular Diseases Botulism |
Neurotoxicity syndromes Poisoning Rare Diseases Disorders of Environmental Origin Clostridium Infections Immunoglobulins |
Immunologic Factors Physiological Effects of Drugs Food Poisoning |
Nervous System Diseases Neuromuscular Junction Diseases Pharmacologic Actions |