- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02055183
BT-010 Registry for the Evaluation of Safety and Clinical Outcomes in Patients Treated With Botulinum Antitoxin
March 14, 2024 updated by: Emergent BioSolutions
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.
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.
Study Overview
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
162
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Participants treated with BAT®
Any patient of any age with a confirmed or suspected exposure to botulinum toxin who were treated with BAT®.
|
Noninterventional, retrospective, observational phase 4 patient Registry
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with serious and non-serious adverse events
Time Frame: From BAT® administration up to discharge from hospital (200 days)
|
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.
|
From BAT® administration up to discharge from hospital (200 days)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants developing acute hypersensitivity
Time Frame: 24 hours
|
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.
|
24 hours
|
Number of participants developing anaphylaxis /anaphylactoid reactions
Time Frame: 24 hours
|
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).
|
24 hours
|
Number of participants developing delayed allergic reaction or serum sickness
Time Frame: 10-21 days
|
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.
|
10-21 days
|
Number of participants developing infusion reactions
Time Frame: 24 hours
|
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.
|
24 hours
|
Number of participants developing febrile reactions
Time Frame: 1 hour
|
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.
|
1 hour
|
Number of participants developing hemodynamic instability
Time Frame: 24 hours
|
A state requiring pharmacologic or mechanical support to maintain a normal blood pressure or adequate cardiac output.
|
24 hours
|
Number of participants developing bradycardia
Time Frame: 24 hours
|
Bradycardia is defined as an abnormally slow heart rate; usually <60 beats per minute in adults.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Jason S Richardson, Ph.D., Emergent BioSolutions
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ruggeberg JU, Gold MS, Bayas JM, Blum MD, Bonhoeffer J, Friedlander S, de Souza Brito G, Heininger U, Imoukhuede B, Khamesipour A, Erlewyn-Lajeunesse M, Martin S, Makela M, Nell P, Pool V, Simpson N; Brighton Collaboration Anaphylaxis Working Group. Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 2007 Aug 1;25(31):5675-84. doi: 10.1016/j.vaccine.2007.02.064. Epub 2007 Mar 12. No abstract available.
- Tacket CO, Shandera WX, Mann JM, Hargrett NT, Blake PA. Equine antitoxin use and other factors that predict outcome in type A foodborne botulism. Am J Med. 1984 May;76(5):794-8. doi: 10.1016/0002-9343(84)90988-4.
- Arnon SS, Schechter R, Inglesby TV, Henderson DA, Bartlett JG, Ascher MS, Eitzen E, Fine AD, Hauer J, Layton M, Lillibridge S, Osterholm MT, O'Toole T, Parker G, Perl TM, Russell PK, Swerdlow DL, Tonat K; Working Group on Civilian Biodefense. Botulinum toxin as a biological weapon: medical and public health management. JAMA. 2001 Feb 28;285(8):1059-70. doi: 10.1001/jama.285.8.1059. Erratum In: JAMA 2001 Apr 25;285(16):2081.
- Black RE, Gunn RA. Hypersensitivity reactions associated with botulinal antitoxin. Am J Med. 1980 Oct;69(4):567-70. doi: 10.1016/0002-9343(80)90469-6.
- Gangarosa EJ, Donadio JA, Armstrong RW, Meyer KF, Brachman PS, Dowell VR. Botulism in the United States, 1899-1969. Am J Epidemiol. 1971 Feb;93(2):93-101. doi: 10.1093/oxfordjournals.aje.a121239. No abstract available.
- Lack JA, Stuart-Taylor ME. Calculation of drug dosage and body surface area of children. Br J Anaesth. 1997 May;78(5):601-5. doi: 10.1093/bja/78.5.601. Erratum In: Br J Anaesth 1997 Aug;79(2):268.
- Lieberman P, Nicklas RA, Oppenheimer J, Kemp SF, Lang DM, Bernstein DI, Bernstein JA, Burks AW, Feldweg AM, Fink JN, Greenberger PA, Golden DB, James JM, Kemp SF, Ledford DK, Lieberman P, Sheffer AL, Bernstein DI, Blessing-Moore J, Cox L, Khan DA, Lang D, Nicklas RA, Oppenheimer J, Portnoy JM, Randolph C, Schuller DE, Spector SL, Tilles S, Wallace D. The diagnosis and management of anaphylaxis practice parameter: 2010 update. J Allergy Clin Immunol. 2010 Sep;126(3):477-80.e1-42. doi: 10.1016/j.jaci.2010.06.022. Epub 2010 Aug 7. Erratum In: J Allergy Clin Immunol. 2010 Dec;126(6):1104.
- Schleis TG. Interference of maltose, icodextrin, galactose, or xylose with some blood glucose monitoring systems. Pharmacotherapy. 2007 Sep;27(9):1313-21. doi: 10.1592/phco.27.9.1313.
- Shapiro RL, Hatheway C, Swerdlow DL. Botulism in the United States: a clinical and epidemiologic review. Ann Intern Med. 1998 Aug 1;129(3):221-8. doi: 10.7326/0003-4819-129-3-199808010-00011.
- Richardson JS, Parrera GS, Astacio H, Sahota H, Anderson DM, Hall C, Babinchak T. Safety and Clinical Outcomes of an Equine-derived Heptavalent Botulinum Antitoxin Treatment for Confirmed or Suspected Botulism in the United States. Clin Infect Dis. 2020 Apr 15;70(9):1950-1957. doi: 10.1093/cid/ciz515.
Helpful Links
- Morbidity and Mortality Weekly Report Center for Disease Control and Prevention. Investigational heptavalent botulinum antitoxin (HBAT™) to replace licensed botulinum antitoxin AB and investigational botulinum antitoxin E.
- Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (BAT™) United States Prescribing Information, 03/2013.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2014
Primary Completion (Actual)
July 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
January 29, 2014
First Submitted That Met QC Criteria
February 3, 2014
First Posted (Estimated)
February 5, 2014
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 14, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Nervous System Diseases
- Infections
- Neuromuscular Diseases
- Foodborne Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Neuromuscular Junction Diseases
- Clostridium Infections
- Poisoning
- Neurotoxicity Syndromes
- Botulism
- Physiological Effects of Drugs
- Immunologic Factors
- Antitoxins
- Botulinum Antitoxin
Other Study ID Numbers
- BT-010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Botulism
-
DynPort Vaccine Company LLC, A GDIT CompanyCompletedBotulism VaccineUnited States
-
Wake Forest University Health SciencesRecruitingBotulism | Iatrogenic BotulismUnited States
-
Centre Hospitalier le MansCompleted
-
California Department of Health ServicesCompletedBotulism | Infant BotulismUnited States
-
California Department of Public HealthCompleted
-
National Institute of Allergy and Infectious Diseases...CompletedBotulismUnited States
-
California Department of Public HealthCompleted
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...Completed
-
DynPort Vaccine Company LLC, A GDIT CompanyWithdrawn
Clinical Trials on BAT
-
Helsinki University Central HospitalOdense University Hospital; University of Oslo; Sahlgrenska University Hospital... and other collaboratorsCompletedResistant HypertensionDenmark, Sweden, Finland, Norway
-
Brian HoustonCVRx, Inc.RecruitingCongestive Heart FailureUnited States
-
Assistance Publique Hopitaux De MarseilleUnknown
-
CelgeneImpact Biomedicines, Inc., a wholly owned subsidiary of Celgene CorporationActive, not recruitingPrimary Myelofibrosis | Myelofibrosis | Post-Polycythemia VeraAustralia, Austria, Belgium, China, Czechia, France, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, Ireland, United Kingdom
-
NYU Langone HealthTerminated
-
Novartis PharmaceuticalsCompletedMyelofibrosisFrance, United Kingdom, Belgium, Germany, Netherlands, Italy, Austria, Spain, Sweden
-
Maimónides Biomedical Research Institute of CórdobaDynamic Solutions; Faes Farma, S.A.; Junta de Andalucía - Consejería de Salud...CompletedSARS-CoV 2 | COVID19 | Cytokine Storm | Cytokine Release Syndrome | SARS (Severe Acute Respiratory Syndrome)Spain
-
Medical College of WisconsinNot yet recruiting
-
Medical College of WisconsinActive, not recruitingType 2 DiabetesUnited States