Botulinum Antitoxin Patient Registry for the Evaluation of Safety and Clinical Outcomes of Pediatric and Adult Patients Following BAT Treatment for Confirmed or Suspected Exposure to Botulinum Toxin.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Emergent BioSolutions
- Enrollment
- 162
- Primary Endpoint
- Number of participants with serious and non-serious adverse events
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts 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
- Not provided
Arms & Interventions
Participants treated with BAT®
Any patient of any age with a confirmed or suspected exposure to botulinum toxin who were treated with BAT®.
Intervention: BAT (Drug)
Outcomes
Primary Outcomes
Number of participants with serious and non-serious adverse events
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported