Study of Human Botulism Immunoglobulin in Infants With Botulism

Sponsor

California Department of Health Services (Other)

Overall Status

Completed

CT.gov ID

NCT00004401

Collaborator

(none)

120

Enrollment

Location

Duration (Months)

24.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

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 or Disease	Intervention/Treatment	Phase
Infant Botulism Botulism	Drug: botulism immune globulin	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 1998

Study Completion Date :

Jun 1, 1998

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 1 Year

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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