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| ID | Type | Description | Link |
|---|---|---|---|
| FD003706 | Other Grant/Funding Number | FDA OOPD |
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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.
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antivenom | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Snake (Micrurus) North American immune F(ab')2 Equine | Drug | 5 vials of study drug reconstituted and diluted to 250 mL Normal Saline and administered intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Survived | Immediately following start of infusion (day 1) through Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Venom Level From Baseline to 24 Hours | Through 24 hours | |
| Change in Mean Antivenom Level From Baseline to 24 Hours | Through 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Boyer, MD | VIPER Institute, University of Arizona | Study Director |
| Jason W. Wilson, MD | Tampa General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Tucson | Arizona | 85724 | United States | ||
| Florida Hospital Deland |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Survived | Posted | Count of Participants | Participants | Immediately following start of infusion (day 1) through Day 22 |
|
|
22 Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Type I immediate hypersensitivity reaction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Regulatory Coordinator | University of Arizona | 520-621-6417 | regulatory@arizona.edu |
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| DeLand |
| Florida |
| 32720 |
| United States |
| Lee Memorial Hospital | Fort Myers | Florida | 33901 | United States |
| St. Lucie Medical Center | Port Saint Lucie | Florida | 34952 | United States |
| Tampa General Hospital | Tampa | Florida | 33601-1289 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Change in Mean Venom Level From Baseline to 24 Hours | Subjects with blood successfully collected at 24 hours | Posted | Mean | Full Range | ng per ml | Through 24 hours |
|
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| Secondary | Change in Mean Antivenom Level From Baseline to 24 Hours | Posted | Mean | Full Range | mcg per ml | Through 24 hours |
|
|
|
| 0 |
| 26 |
| 3 |
| 26 |
| 23 |
| 26 |
| Hospital Re-admission | Infections and infestations | Systematic Assessment | Cellulitis |
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| Alcohol withdrawal resulting in prolonged hospitalization | General disorders | Systematic Assessment |
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| Muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Forgetfulness | Psychiatric disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Runny nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Lightheadedness | Nervous system disorders | Systematic Assessment |
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| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Acute immune reaction | Immune system disorders | Systematic Assessment |
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| Laceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Spider bite | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Numbness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Muscle spasm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Local swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Hyperesthesia | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Blurry vision | Eye disorders | Systematic Assessment |
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| Redness of skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Swollen lymph node | Immune system disorders | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Hypertension | Cardiac disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Swollen lips | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Ethanol withdrawal | General disorders | Systematic Assessment |
|
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