Study of Human Botulism Immunoglobulin in Infants With Botulism

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2000 by FDA Office of Orphan Products Development. Recruitment status was Recruiting

First Received on October 18, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Collaborator:	California Department of Health Services
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004401

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:

MedlinePlus related topics: Bacterial Infections Botulism

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

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

Estimated Enrollment:	120
Study Start Date:	January 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.

Eligibility

Ages Eligible for Study:	up to 1 Year
Genders Eligible for Study:	Both
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

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

Locations

United States, California
California Department of Health Services	Recruiting
Berkeley, California, United States, 94704-1011
Contact: Stephen S. Arnon 510-540-2646

Sponsors and Collaborators

FDA Office of Orphan Products Development

California Department of Health Services

Investigators

Study Chair:

Stephen S. Arnon

California Department of Health Services

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00004401 History of Changes
Other Study ID Numbers:	199/13253, CDHS-FDU000476
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
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:

Botulism
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Neuromuscular Junction Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurotoxicity Syndromes

Foodborne Diseases
Poisoning
Substance-Related Disorders
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012