Clinical trial NCT01337245: Emergency Treatment of Coral Snake Envenomation With Antivenom
Official title: Emergency Treatment of Coral Snake Envenomation With Antivenom
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coral Snake Bite
Toxic Effect of Coral Snake Venom
Keywords: Envenomation
Coral Snake
Antivenom
Micrurus fulvius
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2011-04-18
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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%.

Eligibility 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.

Primary outcomes:
measure: Number of Participants Who Survived
timeFrame: Immediately following start of infusion (day 1) through Day 22
Secondary outcomes:
measure: Change in Mean Venom Level From Baseline to 24 Hours
timeFrame: Through 24 hours
measure: Change in Mean Antivenom Level From Baseline to 24 Hours
timeFrame: Through 24 hours
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University Medical Center
state: Arizona
city: DeLand
country: United States
facility: Florida Hospital Deland
state: Florida
city: Fort Myers
country: United States
facility: Lee Memorial Hospital
state: Florida
city: Port Saint Lucie
country: United States
facility: St. Lucie Medical Center
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
affiliation: VIPER Institute, University of Arizona
name: Leslie Boyer, MD
role: STUDY_DIRECTOR
affiliation: Tampa General Hospital
name: Jason W. Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References: