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BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients
Sponsor: Emergent BioSolutions
Summary
The purpose of this study is to verify the pediatric dosing recommendations for BAT product in pediatric patients that are treated with BAT product due to a confirmed or suspected case of botulism. A minimum of one serum sample should be collected but whenever feasible additional serum samples (up to three per enrolled participant) may be collected from the participant or obtained from surplus standard of care samples, if available, within 32 hours after BAT product administration. Safety of the BAT product will also be evaluated. Emergent will follow-up with the physician by telephone after 30 days post-BAT product administration to collect AEs, SAEs, and unanticipated events.
Official title: Pharmacokinetics of Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (BAT®) in Pediatric Patients With a Confirmed or Suspected Exposure to Botulinum Neurotoxin
Key Details
Gender
All
Age Range
1 Day - 11 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2014-10
Completion Date
2028-07-31
Last Updated
2026-01-16
Healthy Volunteers
No
Conditions
Interventions
Blood sample collection
One to three 5 mL blood samples will be collected from pediatric participants treated with BAT product ideally 6-24 hours after administration but within a maximum of 32 hours after administration.