Emergency Treatment of Coral Snake Envenomation With Antivenom
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|ClinicalTrials.gov Identifier: NCT01337245|
Recruitment Status : Completed
First Posted : April 18, 2011
Last Update Posted : June 8, 2018
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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.
|Condition or disease||Intervention/treatment||Phase|
|Coral Snake Bite Toxic Effect of Coral Snake Venom||Drug: Snake (Micrurus) North American immune F(ab')2 Equine||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Emergency Treatment of Coral Snake Envenomation With Antivenom|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||November 11, 2016|
|Actual Study Completion Date :||November 11, 2016|
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.
- 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 ]
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Male or female of any age. Presenting for emergency treatment of coral snake bite.
- Prior use of coral snake antivenom for this envenomation. Allergy to horse serum.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Fort Myers, Florida, United States, 33901|
|St. Lucie Medical Center|
|Port Saint 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|
|Responsible Party:||University of Arizona|
|Other Study ID Numbers:||
FD003706 ( Other Grant/Funding Number: FDA OOPD )
|First Posted:||April 18, 2011 Key Record Dates|
|Last Update Posted:||June 8, 2018|
|Last Verified:||December 2017|
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