The Efficacy of Crotaline Fab Antivenom for Copperhead Snake Envenomations

NCT00303303 | Terminated Phase 4 Results DMC

• 1 other identifier: 06-01-12B
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 4

Brief Summary

Most patients bitten by copperhead snakes do not currently receive antivenom. Some snakebite victims have long term problems with the function of the limb that was bitten. This study will determine whether early administration of antivenom to patients with mild to moderate copperhead snakebites reduces long-term complications.

Conditions

Snake Envenomation

Keywords

Snake envenomation; Antivenins; Disability evaluation; Activities of daily living

Outcome Measures

Primary Outcomes (4)

• Limb Function: AMA Disability Rating Score of Envenomated Limb

  The range of possible scores is 0 - 100, and a lower score denotes less disability.

  14 days

• Limb Function: AAOS Normative Outcome Study Scoring for Envenomated Limb

  Score ranges from 0-100 with higher scores meaning better function.

  14 days

• Limb Function: AAOS Normative Outcome Study Scoring for Envenomated Limb

  Score ranges from 0-100 with higher scores meaning better function.

  One year

• Limb Function: AAOS--time to Return to Normal Value

  Score ranges from 0-100 with higher scores meaning better function. Time in days to return to baseline value.

  14 days

Secondary Outcomes (8)

• Pain: Visual Analog Score

  14 days

• Pain Medication Use

  First 6 hours from baseline, first 18 hours from baseline, First 24 hours from baseline, 12 months

• Swelling: Percentage (%) of Limb Spread Proximal From Bite Site

  12 months

• Swelling: % Change in Volume Compared to Contralateral (Non-envenomated) Limb

  14 days

• Limb Function: Return to Work

  Week 4

Study Arms (3)

Fab initial and maintenance therapy

EXPERIMENTAL

Active Fab Antivenom initial therapy followed by active Fab antivenom maintenance therapy

Biological: Crotaline Polyvalent Immune Fab (ovine) (active initial and maintenance therapy)

Fab initial therapy; placebo maintenance

EXPERIMENTAL

Active initial Fab antivenom therapy followed by placebo maintenance therapy.

Biological: Crotaline Immune Fab (ovine) (active initial therapy; placebo maintenance therapy)

Placebo initial and maintenance therapy

PLACEBO COMPARATOR

Placebo initial and maintenance therapy.

Biological: Placebo

Interventions

Crotaline Polyvalent Immune Fab (ovine) (active initial and maintenance therapy) BIOLOGICAL

Crotaline Polyvalent Immune Fab (Ovine), 4 vials initially; Second 4-vial dose two hours later if needed to achieve initial control of the envenomation syndrome; active maintenance therapy with 2 vials administered 6, 12, and 18 hours after initial control is achieved.

Also known as: CroFab (tm)

Fab initial and maintenance therapy

Crotaline Immune Fab (ovine) (active initial therapy; placebo maintenance therapy) BIOLOGICAL

Crotaline Polyvalent Immune Fab (Ovine), 4 vials initially; Second 4-vial dose two hours later if needed to achieve initial control of the envenomation syndrome; placebo maintenance therapy administered 6, 12, and 18 hours after initial control is achieved.

Also known as: CroFab (tm)

Fab initial therapy; placebo maintenance

Placebo BIOLOGICAL

Placebo therapy in place of initial and maintenance antivenom therapy. Note that open-label rescue therapy is mandated if the envenomation syndrome becomes severe, or if progression of envenomation signs/symptoms has not spontaneously halted by 6 hours.

Placebo initial and maintenance therapy

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Envenomation by copperhead snake (Agkistrodon contortrix) within 6 hours
• Mild or moderate severity envenomation

You may not qualify if:

• Allergy to antivenom or components
• Severe envenomation (hypotension, severe swelling, compartment syndrome, bleeding, etc.)
• Uncertain snake ID
• Prior treatment with antivenom

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (4)

Carolinas Medical Center

Charlotte, North Carolina, 28232, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Richland Memorial Hospital

Columbia, South Carolina, 29203, United States

Location

Medical College of Virigina/Virginia Commonwealth University Hospital

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Snake Bites

Interventions

Red Meat; Maintenance; Crotalidae Polyvalent immune Fab

Condition Hierarchy (Ancestors)

Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Meat; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: William Kerns II MD Program Directorm Medical Toxicology
• Organization: Carolinas Medical Center

rkerns@carolinas.org

704-355-5297

Study Officials

• William P Kerns, MD

  Carolinas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2006
• First Posted: March 16, 2006
• Study Start: April 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: December 1, 2023
• Results First Posted: December 1, 2023

Record last verified: 2013-08

Locations

US (4)