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Emergency Treatment of Coral Snake Envenomation With Antivenom

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT01337245
First received: April 15, 2011
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  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.


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: September 2013
Estimated Primary Completion Date: September 2013 (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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337245

Locations
United States, Arizona
University Medical Center
Tucson, Arizona, United States, 85724
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33601-1289
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:
VIPER website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT01337245     History of Changes
Other Study ID Numbers: CS-02/08
Study First Received: April 15, 2011
Last Updated: August 7, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Emergencies
Snake Bites
Disease Attributes
Pathologic Processes
Bites and Stings
Poisoning
 Substance-Related Disorders
Antivenins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013