Emergency Treatment of Coral Snake Envenomation With Antivenom

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Arizona
Sponsor:
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT01337245
First received: April 15, 2011
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Coral Snake Bite
Toxic Effect of Coral Snake Venom
Drug: Snake (Micrurus) North American immune F(ab')2 Equine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Emergency Treatment of Coral Snake Envenomation With Antivenom

Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Survival through study period [ Time Frame: Immediately following start of infusion (day 1) through Day 22 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decrease in plasma venom and antivenom levels [ Time Frame: Through Day 22 ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: May 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antivenom
For comparison with historical mortality rate, all patients prospectively enrolled will receive antivenom (Snake [Micrurus] North American immune F(ab')2 Equine) for treatment of coral snake bite.
Drug: Snake (Micrurus) North American immune F(ab')2 Equine
5 vials of study drug reconstituted and diluted to 250 mL Normal Saline and administered intravenously.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01337245

Contacts
Contact: Leslie Boyer, MD 520-626-6229 boyer@viper.arizona.edu
Contact: Janice A Degan, RN 520-626-0242 degan@viper.arizona.edu

Locations
United States, Arizona
University Medical Center Recruiting
Tucson, Arizona, United States, 85724
Principal Investigator: Leslie Boyer, MD         
United States, Florida
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33601-1289
Contact: Cynthia Lewis-Younger, MD    813-844-7044    cyounger@tgh.org   
Sponsors and Collaborators
University of Arizona
Investigators
Study Director: Leslie Boyer, MD VIPER Institute, University of Arizona
Principal Investigator: Cynthia Lewis-Younger, MD Tampa General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT01337245     History of Changes
Other Study ID Numbers: CS-02/08, FD003706
Study First Received: April 15, 2011
Last Updated: January 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arizona:
Envenomation
Coral Snake
Antivenom
Micrurus fulvius

Additional relevant MeSH terms:
Snake Bites
Bites and Stings
Poisoning
Chemically-Induced Disorders
Wounds and Injuries
Antivenins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014