Emergency Treatment of Coral Snake Envenomation With Antivenom

Coral Snake Bite Clinical Trial

Official title:

Emergency Treatment of Coral Snake Envenomation With Antivenom

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01337245
• Other study ID #: CS-02/08
• Secondary ID: FD003706
• Status: Completed
• Phase: Phase 3
• Start date: May 2012
• Est. completion date: November 11, 2016

Study information

• Verified date: May 2023
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 11, 2016
• Est. primary completion date: November 11, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Coral Snake Bite
• Emergencies
• Snake Bites
• Toxic Effect of Coral Snake Venom

Intervention

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.

Locations

Country	Name	City	State
United States	Florida Hospital Deland	DeLand	Florida
United States	Lee Memorial Hospital	Fort Myers	Florida
United States	St. Lucie Medical Center	Port Saint Lucie	Florida
United States	Tampa General Hospital	Tampa	Florida
United States	Banner University Medical Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Survived		Immediately following start of infusion (day 1) through Day 22
Secondary	Change in Mean Venom Level From Baseline to 24 Hours		Through 24 hours
Secondary	Change in Mean Antivenom Level From Baseline to 24 Hours		Through 24 hours