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

NCT02055183 | Completed FDA Drug

• 1 other identifier: BT-010
• Study Type: observational
• Target: 162
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Botulism

Keywords

Registry; Botulinum antitoxin; Botulism Antitoxin Heptavalent- (Equine); BAT®

Outcome Measures

Primary Outcomes (1)

• 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.

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

Other Outcomes (7)

• Number of participants developing acute hypersensitivity

  24 hours

• Number of participants developing anaphylaxis /anaphylactoid reactions

  24 hours

• Number of participants developing delayed allergic reaction or serum sickness

  10-21 days

Study Arms (1)

Participants treated with BAT®

Any patient of any age with a confirmed or suspected exposure to botulinum toxin who were treated with BAT®.

Drug: BAT

Interventions

BAT DRUG

Noninterventional, retrospective, observational phase 4 patient Registry

Also known as: Botulism Antitoxin

Participants treated with BAT®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• Emergent BioSolutions: lead
• Biomedical Advanced Research and Development Authority: collaborator
• Centers for Disease Control and Prevention: collaborator

Related Publications (10)

• 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.

  PMID: 11209178 BACKGROUND

• 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.

  PMID: 7191633 BACKGROUND

• 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.

  PMID: 4925448 BACKGROUND

• 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.

  PMID: 9175982 BACKGROUND

• 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.

  PMID: 20692689 BACKGROUND

• 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.

  PMID: 17448577 BACKGROUND

• 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.

  PMID: 17723085 BACKGROUND

• 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.

  PMID: 9696731 BACKGROUND

• 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.

  PMID: 6720725 BACKGROUND

• 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.

  PMID: 31209461 RESULT

Related 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.

MeSH Terms

Conditions

Botulism

Interventions

Botulinum Antitoxin

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neuromuscular Junction Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurotoxicity Syndromes; Foodborne Diseases; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Antitoxins; Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures

Study Officials

• Jason S Richardson, Ph.D.

  Emergent BioSolutions

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: February 5, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share