Trial record 3 of 3 for:    Open Studies | "Botulism"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Cangene Corporation
Sponsor:
Information provided by (Responsible Party):
Cangene Corporation
ClinicalTrials.gov Identifier:
NCT02055183
First received: January 29, 2014
Last updated: February 3, 2014
Last verified: January 2014
  Purpose

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.


Condition
Botulism

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.

Resource links provided by NLM:


Further study details as provided by Cangene Corporation:

Primary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 100
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)
Groups/Cohorts
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

  Eligibility

Genders Eligible for Study:   Both
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™ deployed from the national or state stockpiles.

Criteria

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™ deployed from the national or state stockpiles.

Exclusion Criteria:

  • None.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02055183

Contacts
Contact: Tim Babinchak, MD 484-318-8851 tbabinchak@cangene.com

Sponsors and Collaborators
Cangene Corporation
  More Information

Additional Information:
Publications:

Responsible Party: Cangene Corporation
ClinicalTrials.gov Identifier: NCT02055183     History of Changes
Other Study ID Numbers: BT-010
Study First Received: January 29, 2014
Last Updated: February 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cangene Corporation:
Registry
Botulinum toxin
Botulism Antitoxin Heptavalent- (Equine)
BAT

Additional relevant MeSH terms:
Botulism
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Neuromuscular Junction Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurotoxicity Syndromes
Foodborne Diseases
Poisoning
Substance-Related Disorders
Antitoxins
Botulinum Antitoxin
Botulinum Toxins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014