Study of Human Botulism Immunoglobulin in Infants With Botulism

This study has been completed.
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: October 18, 1999
Last updated: March 24, 2015
Last verified: March 2000

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
Infant Botulism
Drug: botulism immune globulin

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 120
Study Start Date: January 1998
Estimated Study Completion Date: June 1998
Detailed Description:

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.

Completion date provided represents the completion date of the grant per OOPD records


Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


--Disease Characteristics--

  • Clinical diagnosis of infant botulism in previously healthy infant
  • Bulbar palsies
  • Constipated Lethargy
  • Diminished head control
  • Poor feeding
  • Generalized weakness and hypotonia
  • Weak cry
  • Afebrile (unless secondary infection present)
  • Subacute to acute onset
  • Normal electrolytes
  • Any patient eligible provided no treatment available for life-threatening condition
  Contacts and Locations
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Please refer to this study by its identifier: NCT00004401

United States, California
California Department of Health Services
Berkeley, California, United States, 94704-1011
Sponsors and Collaborators
California Department of Health Services
Study Chair: Stephen S. Arnon California Department of Health Services
  More Information Identifier: NCT00004401     History of Changes
Other Study ID Numbers: 199/13253  CDHS-FDU000476 
Study First Received: October 18, 1999
Last Updated: March 24, 2015
Health Authority: United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
bacterial infection
clostridium infection
immunologic disorders and infectious disorders
infant botulism
rare disease

Additional relevant MeSH terms:
Bacterial Infections
Chemically-Induced Disorders
Clostridium Infections
Foodborne Diseases
Gram-Positive Bacterial Infections
Nervous System Diseases
Neuromuscular Diseases
Neuromuscular Junction Diseases
Neurotoxicity Syndromes
Immunologic Factors
Physiological Effects of Drugs processed this record on May 26, 2016