Study of Human Botulism Immunoglobulin in Infants With Botulism

Botulism Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004401
• Other study ID #: 199/13253
• Secondary ID: CDHS-FDU000476
• Status: Completed
• Phase: N/A
• First received: October 18, 1999
• Last updated: March 24, 2015
• Start date: January 1998
• Est. completion date: June 1998

Study information

• Verified date: March 2000
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Botulism
• Infant Botulism

Intervention

Drug:
• botulism immune globulin

Locations

Country	Name	City	State
United States	California Department of Health Services	Berkeley	California

Sponsors (1)

Lead Sponsor	Collaborator
California Department of Health Services

Country where clinical trial is conducted

United States,