Emergency Treatment of Coral Snake Envenomation With Antivenom

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Arizona
Sponsor:
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT01337245
First received: April 15, 2011
Last updated: January 31, 2014
Last verified: January 2014

April 15, 2011
January 31, 2014
May 2012
March 2016   (final data collection date for primary outcome measure)
Survival through study period [ Time Frame: Immediately following start of infusion (day 1) through Day 22 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01337245 on ClinicalTrials.gov Archive Site
Decrease in plasma venom and antivenom levels [ Time Frame: Through Day 22 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Emergency Treatment of Coral Snake Envenomation With Antivenom
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.

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%.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coral Snake Bite
  • Toxic Effect of Coral Snake Venom
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.
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.
Intervention: Drug: Snake (Micrurus) North American immune F(ab')2 Equine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
55
March 2016
March 2016   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact: Leslie Boyer, MD 520-626-6229 boyer@viper.arizona.edu
Contact: Janice A Degan, RN 520-626-0242 degan@viper.arizona.edu
United States
 
NCT01337245
CS-02/08, FD003706
Yes
University of Arizona
University of Arizona
Not Provided
Study Director: Leslie Boyer, MD VIPER Institute, University of Arizona
Principal Investigator: Cynthia Lewis-Younger, MD Tampa General Hospital
University of Arizona
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP