Skip to main content
OpenTrials
Completed

NCT Number: NCT01337245

Emergency Treatment of Coral Snake Envenomation With Antivenom

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coral Snake Bite Toxic Effect of Coral Snake Venom

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Banner University Medical Center, Tucson, Arizona, United States

Loading trial locations.

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Snake (Micrurus) North American immune F(ab')2 Equine

Drug

5 vials of study drug reconstituted and diluted to 250 mL Normal Saline and administered intravenously.

Primary outcomes

  1. Number of Participants Who Survived

    Time frame: Immediately following start of infusion (day 1) through Day 22

Secondary outcomes

  1. Change in Mean Venom Level From Baseline to 24 Hours

    Time frame: Through 24 hours

  2. Change in Mean Antivenom Level From Baseline to 24 Hours

    Time frame: Through 24 hours

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 18, 2011
Registry last updated
May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.