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 Bite Toxic Effect of Coral Snake Venom||Drug: Snake (Micrurus) North American immune F(ab')2 Equine||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Emergency Treatment of Coral Snake Envenomation With Antivenom|
- Survival through study period [ Time Frame: Immediately following start of infusion (day 1) through Day 22 ]
- Decrease in plasma venom and antivenom levels [ Time Frame: Through Day 22 ]
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||November 2017|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
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.
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%.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337245
|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|
|Ft. Myers, Florida, United States, 33901|
|St. Lucie Medical Center|
|Port St. Lucie, Florida, United States, 34952|
|Tampa General Hospital|
|Tampa, Florida, United States, 33601-1289|
|Study Director:||Leslie Boyer, MD||VIPER Institute, University of Arizona|
|Principal Investigator:||Jason W. Wilson, MD||Tampa General Hospital|