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OpenTrials
Completed

NCT Number: NCT00004401

Study of Human Botulism Immunoglobulin in Infants With Botulism

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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Key information

Conditions

Infant Botulism Bacterial Infections Bacterial Infections and Mycoses Botulism Chemically-Induced Disorders Clostridium Infections Communicable Diseases Disease Attributes Foodborne Diseases Gram-Positive Bacterial Infections Immune System Diseases Infections Nervous System Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Neurotoxicity Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Poisoning Rare Diseases

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

California Department of Health Services

Berkeley, California, 94704-1011, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

botulism immune globulin

Drug

Sponsors and collaborators

Lead sponsor

California Department of Health Services

Other

Registry information

Important dates

Study start
1998
Study completion
1998
First posted
Oct 19, 1999
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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