Study of Human Botulism Immunoglobulin in Infants With Botulism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Study Completion Date

1998-06-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Infant Botulism Botulism

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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botulism immune globulin

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No