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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

Page last updated: August 20, 2015

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