Clinical trial NCT02055183: BT-010 Registry for the Evaluation of Safety and Clinical Outcomes in Patients Treated With Botulinum Antitoxin
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Botulism
Keywords: Registry
Botulinum antitoxin
Botulism Antitoxin Heptavalent- (Equine)
BAT®
Lead sponsor: Emergent BioSolutions
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
name: Centers for Disease Control and Prevention
First posted: 2014-02-05
Enrollment: 162
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with serious and non-serious adverse events
timeFrame: From BAT® administration up to discharge from hospital (200 days)
Secondary outcomes:
Other outcomes:
measure: Number of participants developing acute hypersensitivity
timeFrame: 24 hours
measure: Number of participants developing anaphylaxis /anaphylactoid reactions
timeFrame: 24 hours
measure: Number of participants developing delayed allergic reaction or serum sickness
timeFrame: 10-21 days
measure: Number of participants developing infusion reactions
timeFrame: 24 hours
measure: Number of participants developing febrile reactions
timeFrame: 1 hour
measure: Number of participants developing hemodynamic instability
timeFrame: 24 hours
measure: Number of participants developing bradycardia
timeFrame: 24 hours
Locations:
Study officials:
affiliation: Emergent BioSolutions
name: Jason S Richardson, Ph.D.
role: STUDY_CHAIR
References:
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citation: Richardson JS, Parrera GS, Astacio H, Sahota H, Anderson DM, Hall C, Babinchak T. Safety and Clinical Outcomes of an Equine-derived Heptavalent Botulinum Antitoxin Treatment for Confirmed or Suspected Botulism in the United States. Clin Infect Dis. 2020 Apr 15;70(9):1950-1957. doi: 10.1093/cid/ciz515.