Study of Human Botulism Immunoglobulin in Infants With Botulism
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any - 1 |
| Updated: | 3/16/2015 |
| Start Date: | January 1998 |
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.
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.
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.
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.
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
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