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Study of Human Botulism Immunoglobulin in Infants With Botulism

This study has been completed.
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004401
First received: October 18, 1999
Last updated: March 24, 2015
Last verified: March 2000
  Purpose

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 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

  Eligibility

Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

--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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004401

Locations
United States, California
California Department of Health Services
Berkeley, California, United States, 94704-1011
Sponsors and Collaborators
California Department of Health Services
Investigators
Study Chair: Stephen S. Arnon California Department of Health Services
  More Information

ClinicalTrials.gov Identifier: NCT00004401     History of Changes
Other Study ID Numbers: 199/13253
CDHS-FDU000476
Study First Received: October 18, 1999
Last Updated: March 24, 2015

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:
Botulism
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Neuromuscular Junction Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurotoxicity Syndromes
Foodborne Diseases
Poisoning
Chemically-Induced Disorders
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2017