Trial Outcomes & Findings for Emergency Treatment of Coral Snake Envenomation With Antivenom (NCT NCT01337245)
NCT ID: NCT01337245
Last Updated: 2023-05-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
26 participants
Primary outcome timeframe
Immediately following start of infusion (day 1) through Day 22
Results posted on
2023-05-26
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Emergency Treatment of Coral Snake Envenomation With Antivenom
Baseline characteristics by cohort
| Measure |
Antivenom
n=26 Participants
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.
|
|---|---|
|
Age, Continuous
|
39.7 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
23 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Unknown
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Immediately following start of infusion (day 1) through Day 22Outcome measures
| Measure |
Antivenom
n=25 Participants
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.
|
|---|---|
|
Number of Participants Who Survived
|
25 Participants
|
SECONDARY outcome
Timeframe: Through 24 hoursPopulation: Subjects with blood successfully collected at 24 hours
Outcome measures
| Measure |
Antivenom
n=23 Participants
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.
|
|---|---|
|
Change in Mean Venom Level From Baseline to 24 Hours
|
-34.5 ng per ml
Interval -353.0 to 0.0
|
SECONDARY outcome
Timeframe: Through 24 hoursOutcome measures
| Measure |
Antivenom
n=23 Participants
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.
|
|---|---|
|
Change in Mean Antivenom Level From Baseline to 24 Hours
|
112.4 mcg per ml
Interval 62.6 to 236.4
|
Adverse Events
Antivenom
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Antivenom
n=26 participants at risk
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.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Type I immediate hypersensitivity reaction
|
3.8%
1/26 • Number of events 1 • 22 Days
|
|
Infections and infestations
Hospital Re-admission
|
3.8%
1/26 • Number of events 1 • 22 Days
|
|
General disorders
Alcohol withdrawal resulting in prolonged hospitalization
|
3.8%
1/26 • Number of events 1 • 22 Days
|
Other adverse events
| Measure |
Antivenom
n=26 participants at risk
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.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
23.1%
6/26 • Number of events 6 • 22 Days
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
11.5%
3/26 • Number of events 3 • 22 Days
|
|
Psychiatric disorders
Forgetfulness
|
3.8%
1/26 • Number of events 1 • 22 Days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
1/26 • Number of events 1 • 22 Days
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
7.7%
2/26 • Number of events 2 • 22 Days
|
|
Nervous system disorders
Lightheadedness
|
7.7%
2/26 • Number of events 2 • 22 Days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
19.2%
5/26 • Number of events 8 • 22 Days
|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
2/26 • Number of events 2 • 22 Days
|
|
Immune system disorders
Acute immune reaction
|
23.1%
6/26 • Number of events 8 • 22 Days
|
|
Skin and subcutaneous tissue disorders
Laceration
|
3.8%
1/26 • Number of events 1 • 22 Days
|
|
Skin and subcutaneous tissue disorders
Spider bite
|
3.8%
1/26 • Number of events 1 • 22 Days
|
|
Skin and subcutaneous tissue disorders
Numbness
|
7.7%
2/26 • Number of events 2 • 22 Days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
3.8%
1/26 • Number of events 1 • 22 Days
|
|
Nervous system disorders
Headache
|
3.8%
1/26 • Number of events 1 • 22 Days
|
|
Skin and subcutaneous tissue disorders
Local swelling
|
15.4%
4/26 • Number of events 4 • 22 Days
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
7.7%
2/26 • Number of events 2 • 22 Days
|
|
Renal and urinary disorders
Hematuria
|
3.8%
1/26 • Number of events 1 • 22 Days
|
|
Skin and subcutaneous tissue disorders
Hyperesthesia
|
3.8%
1/26 • Number of events 1 • 22 Days
|
|
Eye disorders
Blurry vision
|
3.8%
1/26 • Number of events 1 • 22 Days
|
|
Skin and subcutaneous tissue disorders
Redness of skin
|
3.8%
1/26 • Number of events 1 • 22 Days
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
7.7%
2/26 • Number of events 2 • 22 Days
|
|
Immune system disorders
Swollen lymph node
|
3.8%
1/26 • Number of events 1 • 22 Days
|
|
Renal and urinary disorders
Acute kidney injury
|
3.8%
1/26 • Number of events 1 • 22 Days
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Number of events 1 • 22 Days
|
|
Cardiac disorders
Hypertension
|
3.8%
1/26 • Number of events 1 • 22 Days
|
|
Psychiatric disorders
Anxiety
|
3.8%
1/26 • Number of events 1 • 22 Days
|
|
Skin and subcutaneous tissue disorders
Swollen lips
|
3.8%
1/26 • Number of events 1 • 22 Days
|
|
General disorders
Ethanol withdrawal
|
3.8%
1/26 • Number of events 1 • 22 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place