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Study of Human Botulism Immunoglobulin in Infants With Botulism

NCT00004401 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-03-25

No results posted yet for this study

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.

Conditions

  • Infant Botulism
  • Botulism

Interventions

DRUG

botulism immune globulin

Sponsors & Collaborators

  • California Department of Health Services

    lead OTHER

Principal Investigators

  • Stephen S. Arnon · California Department of Health Services

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-01-31
Completion
1998-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004401 on ClinicalTrials.gov