CompletedNot Applicable

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

162 participantsStarted 2014-10

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of participants with serious and non-serious adverse events

Timeframe: From BAT® administration up to discharge from hospital (200 days)

Trial details

NCT IDNCT02055183

SponsorEmergent BioSolutions

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-07

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