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.
Protocol Amendment History
13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2014-01-29; most recent amendment 2026-01-14.
Status change: Active, Not Recruiting → Enrolling by Invitation2022-11-15
Status change: Completed → Active, Not Recruiting2022-05-02
Status change: Enrolling by Invitation → Completed2018-01-24
Status change: Not Yet Recruiting → Enrolling by Invitation2014-12-23