NCT02055183

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

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 162 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Botulism

Interventions

Type	Name	Description
DRUG	BAT	Noninterventional, retrospective, observational phase 4 patient Registry

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2014-02-05
• Last updated: 2024-03-15

Regulatory

• FDA-regulated drug study