An observational study in Botulism, sponsored by Emergent BioSolutions. Completed. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by Emergent BioSolutions · Observational
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.
A full description of the patient registry can be found in the paper titled: Safety and Clinical Outcomes of an Equine-derived Heptavalent Botulinum Antitoxin Treatment for Confirmed or Suspected Botulism in the United States. Richardson JS, Parrera GS, Astacio H, Sahota H, Anderson DM, Hall C, Babinchak T. Clin Infect Dis. 2019 Apr 15;70(9):1950-1957.
20 studies on the registry are indexed under Botulism; 3 are open to participants now.
Browse Botulism studies →Emergent BioSolutions is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any patient of any age with a confirmed or suspected exposure to botulinum toxin who were treated with BAT®.
Drug: BAT
Noninterventional, retrospective, observational phase 4 patient Registry
Also known as: Botulism Antitoxin
Number of participants with serious and non-serious adverse events
The data obtained will more clearly define the absolute risk (incidence rates) of hypersensitivity/allergic reactions, including serum sickness, febrile reactions, hemodynamic instability, bradycardia, and other serious adverse events in pediatric and adult patients that are treated with BAT® due to a confirmed or suspected case of botulism.
Time frame: From BAT® administration up to discharge from hospital (200 days)
Number of participants developing acute hypersensitivity
Reactions that may occur shortly after exposure to BAT® and can include, but are not limited to, urticaria, pruritus, erythema, angioedema, bronchospasm with wheezing or cough, stridor, laryngeal edema, hypotension, or tachycardia.
Time frame: 24 hours
Number of participants developing anaphylaxis /anaphylactoid reactions
Severe form of acute, severe hypersensitivity reaction with multiorgan system involvement that occurs with sudden onset after exposure to an allergen. Case definition of anaphylaxis requires a sudden onset and rapid progression of signs and symptoms and involvement of multiple (≥ 2) organ systems (cardiovascular, dermatological or respiratory).
Time frame: 24 hours
Number of participants developing delayed allergic reaction or serum sickness
This includes symptoms such as, but not limited to, fever, urticarial or maculopapular rash, myalgia, arthralgia, and lymphadenopathy occurring 10-21 days after BAT® infusion.
Time frame: 10-21 days
Number of participants developing infusion reactions
Infusion reactions are unexpected reactions that cannot be explained by the known toxicity profile of the drug. Infusion reactions are the result of the infusion process (rate, volume, etc.) and are often referred to as "hypersensitivity reactions" as well. In the absence of an allergic component, the term "infusion reaction" is preferred. Infusion reactions may affect any organ system in the body. Most are mild in severity, although severe and fatal reactions may occur. The most common signs and symptoms may include, but are not limited to flushing, itching, alterations in heart rate and blood pressure, dyspnea or chest discomfort, back or abdominal pain, fever and/or shaking chills (rigors), nausea, vomiting, and/or diarrhea, skin rashes, throat tightening, hypoxia, seizures, dizziness and/or syncope.
Time frame: 24 hours
Number of participants developing febrile reactions
Febrile reaction is an absolute temperature \> 38.1°C or an increase in temperature \>1°C above baseline temperature that occurs during or within 1 hour of BAT® infusion and is unrelated to the underlying illness.
Time frame: 1 hour
Number of participants developing hemodynamic instability
A state requiring pharmacologic or mechanical support to maintain a normal blood pressure or adequate cardiac output.
Time frame: 24 hours
Number of participants developing bradycardia
Bradycardia is defined as an abnormally slow heart rate; usually \<60 beats per minute in adults.
Time frame: 24 hours
No study locations are listed for this record.
Plan to share: No
Ran from Oct 2014 to primary completion in Jul 2017, 33 months.
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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