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Emergency Treatment of Coral Snake Envenomation With Antivenom

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ClinicalTrials.gov Identifier: NCT01337245
Recruitment Status : Completed
First Posted : April 18, 2011
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
University of Arizona

Study Description
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Brief 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.


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

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%.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Emergency Treatment of Coral Snake Envenomation With Antivenom
Study Start Date : May 2012
Actual Primary Completion Date : November 11, 2016
Actual Study Completion Date : November 11, 2016
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Survival through study period [ Time Frame: Immediately following start of infusion (day 1) through Day 22 ]

Secondary Outcome Measures :
  1. Decrease in plasma venom and antivenom levels [ Time Frame: Through Day 22 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337245


Locations
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United States, Arizona
Banner University Medical Center
Tucson, Arizona, United States, 85724
United States, Florida
Florida Hospital Deland
DeLand, Florida, United States, 32720
Lee Memorial Hospital
Fort Myers, Florida, United States, 33901
St. Lucie Medical Center
Port Saint Lucie, Florida, United States, 34952
Tampa General Hospital
Tampa, Florida, United States, 33601-1289
Sponsors and Collaborators
University of Arizona
Investigators
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Study Director: Leslie Boyer, MD VIPER Institute, University of Arizona
Principal Investigator: Jason W. Wilson, MD Tampa General Hospital
More Information
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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT01337245    
Other Study ID Numbers: CS-02/08
FD003706 ( Other Grant/Funding Number: FDA OOPD )
First Posted: April 18, 2011    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: December 2017
Keywords provided by University of Arizona:
Envenomation
Coral Snake
Antivenom
Micrurus fulvius
Additional relevant MeSH terms:
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Emergencies
Snake Bites
Disease Attributes
Pathologic Processes
 Bites and Stings
Poisoning
Chemically-Induced Disorders
Wounds and Injuries