Emergency Treatment of Coral Snake Envenomation With Antivenom
Information source: University of Arizona
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coral Snake Bite; Toxic Effect of Coral Snake Venom
Intervention: Snake (Micrurus) North American immune F(ab')2 Equine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of Arizona Official(s) and/or principal investigator(s): Leslie Boyer, MD, Study Director, Affiliation: VIPER Institute, University of Arizona Jason W. Wilson, MD, Principal Investigator, Affiliation: Tampa General Hospital
Overall contact: Leslie Boyer, MD, Phone: 520-626-6229, Email: boyer@viper.arizona.edu
Summary
The purpose of this study is to see whether a new F(ab')2 antivenom will prevent injury and
death from the bite of a coral snake.
Funding Source - FDA OOPD.
Clinical Details
Official title: Emergency Treatment of Coral Snake Envenomation With Antivenom
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Survival through study period
Secondary outcome: Decrease in plasma venom and antivenom levels
Detailed description:
Coral snake bites may be trivial in effect, or they may cause profound and life-threatening
respiratory paralysis, depending on the severity of the envenomation. Venom toxins target
the neuromuscular junction, where effects typically become apparent hours following the
bite, by which time the clinical syndrome may be irreversible. Unless neurotoxicity is
prevented, ventilatory paralysis may cause death or require intensive care for weeks after
the bite. Prevention of paralysis, historically, has involved treating all bite victims with
antivenom.
This protocol will enable the therapeutic use of a new F(ab')2 antivenom in the management
of coral snake envenomation.
Following a coral snake bite, patients who meet inclusion/exclusion criteria and who provide
informed consent will receive 5 vials of antivenom intravenously over no less than 30
minutes. Blood assays for venom levels and clinical assessments of neurologic status before
and after treatment will be conducted and patients will be followed for 22 days for safety
and survival endpoints.
The primary endpoint of this Phase 3 trial will be survival, for comparison with a
historical mortality rate of 15%.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female of any age. Presenting for emergency treatment of coral snake bite.
Exclusion Criteria:
- Prior use of coral snake antivenom for this envenomation. Allergy to horse serum.
Locations and Contacts
Leslie Boyer, MD, Phone: 520-626-6229, Email: boyer@viper.arizona.edu
University Medical Center, Tucson, Arizona 85724, United States; Recruiting Leslie Boyer, MD, Principal Investigator
Florida Hospital Deland, Deland, Florida 32720, United States; Recruiting Beth Hooks, RN BSN MBA, Phone: 386-943-4656, Email: beth.hooks@fhdeland.org Matthew Bazel, PharmD, Phone: 386-943-4780, Email: Matthew.Bazel@fhdeland.org Tracy Weiner, DO, Principal Investigator
Lee Memorial Hospital, Ft. Myers, Florida 33901, United States; Recruiting Pam Fowler, RN BS CIM, Phone: 239-424-3383, Email: pam.fowler@leememorial.org Edward Newton, Pharm.D, Phone: 239-343-3203, Email: edward.newton@leememorial.org Douglas Lee, MD, Principal Investigator
Tampa General Hospital, Tampa, Florida 33601-1289, United States; Recruiting Jason W. Wilson, MD, Phone: 813-843-2110, Email: tampaerdoc@gmail.com
Additional Information
VIPER website
Starting date: May 2012
Last updated: June 9, 2015
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