Emergency Treatment of Coral Snake Envenomation With Antivenom

May 2, 2023 updated by: University of Arizona

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Banner University Medical Center
    • Florida
      • DeLand, Florida, United States, 32720
        • Florida Hospital DeLand
      • Fort Myers, Florida, United States, 33901
        • Lee Memorial Hospital
      • Port Saint Lucie, Florida, United States, 34952
        • St. Lucie Medical Center
      • Tampa, Florida, United States, 33601-1289
        • Tampa General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Who Survived
Time Frame: Immediately following start of infusion (day 1) through Day 22
Immediately following start of infusion (day 1) through Day 22

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Mean Venom Level From Baseline to 24 Hours
Time Frame: Through 24 hours
Through 24 hours
Change in Mean Antivenom Level From Baseline to 24 Hours
Time Frame: Through 24 hours
Through 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Investigators

  • Study Director: Leslie Boyer, MD, VIPER Institute, University of Arizona
  • Principal Investigator: Jason W. Wilson, MD, Tampa General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

November 11, 2016

Study Completion (Actual)

November 11, 2016

Study Registration Dates

First Submitted

April 15, 2011

First Submitted That Met QC Criteria

April 15, 2011

First Posted (Estimated)

April 18, 2011

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-02/08
  • FD003706 (Other Grant/Funding Number: FDA OOPD)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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