BT-010 Registry for the Evaluation of Safety and Clinical Outcomes in Patients Treated With Botulinum Antitoxin

Emergent BioSolutions

Status: Completed

Conditions: Botulism

Treatments: Drug: BAT

Study type: Observational

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT02055183

BT-010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

162 participants in 1 patient group

Participants treated with BAT®

Description:

Any patient of any age with a confirmed or suspected exposure to botulinum toxin who were treated with BAT®.

Treatment:

Drug: BAT