Registry for the Evaluation of Safety and Clinical Outcomes in Patients Treated With Botulinum Antitoxin
The purpose of the Registry will be 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. This Registry is intended to serve as an active surveillance system to further assess the safety profile for BAT™ and to quantify the occurrence of unexpected adverse events, given that the current safety database is considered too small to reliably identify unexpected risks.
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Target Follow-Up Duration:||6 Months|
|Official Title:||Botulinum Antitoxin Patient Registry for the Evaluation of Safety and Clinical Outcomes of Pediatric and Adult Patients Following BAT Treatment for Confirmed or Suspected Exposure to Botulinum Toxin.|
- Number of participants with serious and non-serious adverse events [ Time Frame: From BAT administration up to discharge from hospital (200 days) ] [ Designated as safety issue: Yes ]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.
- Number of participants developing acute hypersensitivity [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]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.
- Number of participants developing anaphylaxis /anaphylactoid reactions [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]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).
- Number of participants developing delayed allergic reaction or serum sickness [ Time Frame: 10-21 days ] [ Designated as safety issue: Yes ]This includes symptoms such as, but not limited to, fever, urticarial or maculopapular rash, myalgia, arthralgia, and lymphadenopathy occurring 10-21 days after infusion.
- Number of participants developing infusion reactions [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]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.
- Number of participants developing febrile reactions [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]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.
- Number of participants developing hemodynamic instability [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]A state requiring pharmacologic or mechanical support to maintain a normal blood pressure or adequate cardiac output.
- Number of participants developing bradycardia [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]Bradycardia is defined as an abnormally slow heart rate; usually < 60 beats per minute in adults.
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Participants treated with BAT
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™ deployed from the national or state stockpiles.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02055183
|Contact: Tim Babinchak, MDfirstname.lastname@example.org|