BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients

Enrolling by invitation · Phase 4

Conditions studied: Botulism

In brief

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.

Key facts

Study ID

NCT02051062

Run by

Emergent BioSolutions

People needed

10

Starts

2014-10-01

Expected to finish

2028-07-31

Last updated by the study team

2026-01-16

Who can join

Age: 0 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Legally authorized representative is able and willing to voluntarily provide informed consent and patients to provide assent, if applicable.
• Pediatric participants (age groups: birth to <two years, two to <six years, and six to <12 years).
• Treatment with BAT product (initial dose only).
• Blood sample can be collected (or standard of care sample scavenged) within 32 hours of completion of BAT product infusion.

You may not qualify if…

• If the 5 mL blood sample volume is deemed, at the discretion of the investigator, to be unsafe based on patient weight or condition of health.
• History of treatment with BabyBIG or other botulism antitoxin within the past 90 days.

Full record on ClinicalTrials.gov

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