Botulism
Conditions
Keywords
Registry, Botulinum antitoxin, Botulism Antitoxin Heptavalent- (Equine), BAT®
Brief summary
The purpose of the Registry was to evaluate patient safety following Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (BAT®) administration in adult and pediatric patients with a confirmed or suspected exposure to botulinum toxin.
Detailed description
A full description of the patient registry can be found in the paper titled: Safety and Clinical Outcomes of an Equine-derived Heptavalent Botulinum Antitoxin Treatment for Confirmed or Suspected Botulism in the United States. Richardson JS, Parrera GS, Astacio H, Sahota H, Anderson DM, Hall C, Babinchak T. Clin Infect Dis. 2019 Apr 15;70(9):1950-1957.
Interventions
DRUGBAT
Noninterventional, retrospective, observational phase 4 patient Registry
Sponsors
Biomedical Advanced Research and Development Authority
Centers for Disease Control and Prevention
Emergent BioSolutions
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Any patient of any age \[age category: pediatric-newborn infants (0 to 27 days), infants and toddlers (28 days to 23 months), children (2 to 11-years), and adolescents (12 to \<17-years); adult (17-64-years); and geriatric (≥65-years)\] with a confirmed or suspected exposure to botulinum toxin who were treated with BAT® provided by the CDC.
Exclusion criteria
* None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with serious and non-serious adverse events | From BAT® administration up to discharge from hospital (200 days) | The data obtained will more clearly define the absolute risk (incidence rates) of hypersensitivity/allergic reactions, including serum sickness, febrile reactions, hemodynamic instability, bradycardia, and other serious adverse events in pediatric and adult patients that are treated with BAT® due to a confirmed or suspected case of botulism. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants developing anaphylaxis /anaphylactoid reactions | 24 hours | Severe form of acute, severe hypersensitivity reaction with multiorgan system involvement that occurs with sudden onset after exposure to an allergen. Case definition of anaphylaxis requires a sudden onset and rapid progression of signs and symptoms and involvement of multiple (≥ 2) organ systems (cardiovascular, dermatological or respiratory). |
| Number of participants developing delayed allergic reaction or serum sickness | 10-21 days | This includes symptoms such as, but not limited to, fever, urticarial or maculopapular rash, myalgia, arthralgia, and lymphadenopathy occurring 10-21 days after BAT® infusion. |
| Number of participants developing infusion reactions | 24 hours | Infusion reactions are unexpected reactions that cannot be explained by the known toxicity profile of the drug. Infusion reactions are the result of the infusion process (rate, volume, etc.) and are often referred to as hypersensitivity reactions as well. In the absence of an allergic component, the term infusion reaction is preferred. Infusion reactions may affect any organ system in the body. Most are mild in severity, although severe and fatal reactions may occur. The most common signs and symptoms may include, but are not limited to flushing, itching, alterations in heart rate and blood pressure, dyspnea or chest discomfort, back or abdominal pain, fever and/or shaking chills (rigors), nausea, vomiting, and/or diarrhea, skin rashes, throat tightening, hypoxia, seizures, dizziness and/or syncope. |
| Number of participants developing acute hypersensitivity | 24 hours | Reactions that may occur shortly after exposure to BAT® and can include, but are not limited to, urticaria, pruritus, erythema, angioedema, bronchospasm with wheezing or cough, stridor, laryngeal edema, hypotension, or tachycardia. |
| Number of participants developing hemodynamic instability | 24 hours | A state requiring pharmacologic or mechanical support to maintain a normal blood pressure or adequate cardiac output. |
| Number of participants developing bradycardia | 24 hours | Bradycardia is defined as an abnormally slow heart rate; usually \<60 beats per minute in adults. |
| Number of participants developing febrile reactions | 1 hour | Febrile reaction is an absolute temperature \> 38.1°C or an increase in temperature \>1°C above baseline temperature that occurs during or within 1 hour of BAT® infusion and is unrelated to the underlying illness. |
Outcome results
None listed