Emergency Treatment of Coral Snake Envenomation With Anacoral Antivenom
Information source: University of Arizona
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coral Snake Bite; Toxic Effect of Coral Snake Venom
Intervention: Snake (Micrurus) North American immune F(ab')2 (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: University of Arizona Official(s) and/or principal investigator(s):
Leslie Boyer, MD, Study Director, Affiliation: VIPER Institute, University of Arizona
Overall contact:
Leslie Boyer, MD, Phone: 520-626-6229, Email: boyer@viper.arizona.edu
Summary
The purpose of this study is to see whether Anacoral, a type of antivenom, will prevent
injury and death from the bite of a coral snake.
Clinical Details
Official title: Emergency Treatment of Coral Snake Envenomation With Anacoral Antivenom
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Survival through study period
Secondary outcome: Decrease in plasma venom and antivenom levels
Detailed 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 Anacoral, 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 Anacoral intravenous 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%.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Leslie Boyer, MD, Phone: 520-626-6229, Email: boyer@viper.arizona.edu
University Medical Center, Tucson, Arizona 85724, United States
Additional Information
VIPER website
Starting date: June 2011
Last updated: April 15, 2011
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