Clinical trial
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.
Name
BT-010
Description
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.
Trial arms
Trial start
2014-10-01
Estimated PCD
2017-07-01
Trial end
2017-07-01
Status
Completed
Treatment
BAT
Noninterventional, retrospective, observational phase 4 patient Registry
Arms:
Participants treated with BAT®
Other names:
Botulism Antitoxin
Size
162
Primary endpoint
Number of participants with serious and non-serious adverse events
From BAT® administration up to discharge from hospital (200 days)
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '6 Months', 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 162, 'type': 'ACTUAL'}}
Updated at
2024-03-15
1 organization
1 product
1 indication
Organization
Emergent BiosolutionsProduct
BATIndication
Botulism