Charles J Gerardo1, Eugenia Quackenbush2, Brandon Lewis3, S Rutherfoord Rose4, Spencer Greene5, Eric A Toschlog6, Nathan P Charlton7, Michael E Mullins8, Richard Schwartz9, David Denning10, Kapil Sharma11, Kurt Kleinschmidt11, Sean P Bush12, Samantha Ryan13, Maria Gasior14, Victoria E Anderson15, Eric J Lavonas16. 1. Division of Emergency Medicine, Duke University School of Medicine, Durham, NC. Electronic address: Charles.gerardo@duke.edu. 2. Department of Emergency Medicine, University of North Carolina School of Medicine, Chapel Hill, NC. 3. Department of Emergency Services, St Joseph Regional Health Center, Bryan, TX, and Texas A&M University Health Science Center, College Station, TX. 4. Department of Emergency Medicine, Virginia Commonwealth University School of Medicine, Richmond, VA. 5. Section of Emergency Medicine, Baylor College of Medicine, Houston, TX. 6. Department of Surgery, East Carolina University, Greenville, NC. 7. Department of Emergency Medicine, University of Virginia, Charlottesville, VA. 8. Division of Emergency Medicine, Washington University School of Medicine, St. Louis, MO. 9. Department of Emergency Medicine, Augusta University, Augusta, GA. 10. Department of Surgery, Marshall Health, Huntington, WV. 11. Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, TX. 12. Department of Emergency Medicine, East Carolina University Brody School of Medicine, Greenville, NC. 13. BTG International Inc, London, UK. 14. BTG International Inc, West Conshohocken, PA. 15. Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, CO. 16. Department of Emergency Medicine, Denver Health and Hospital Authority, Denver, CO; Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, CO; Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO.
Abstract
STUDY OBJECTIVE:Copperhead snake (Agkistrodon contortrix) envenomation causes limb injury resulting in pain and disability. It is not known whether antivenom administration improves limb function. We determine whether administration of antivenom improves recovery from limb injury in patients envenomated by copperhead snakes. METHODS:From August 2013 through November 2015, we performed a multicenter, randomized, double-blind, placebo-controlled, clinical trial to evaluate the effect of ovine Crotalidae polyvalent immune Fab (ovine) (CroFab; FabAV) antivenom therapy on recovery of limb function in patients with copperhead snake envenomation at 14 days postenvenomation. The study setting was 18 emergency departments in regions of the United States where copperhead snakes are endemic. Consecutive patients aged 12 years or older with mild- to moderate-severity envenomation received eitherFabAV or placebo. The primary outcome was limb function 14 days after envenomation, measured by the Patient-Specific Functional Scale. Additional outcomes included the Patient-Specific Functional Scale at other points; the Disorders of the Arm, Shoulder, and Hand, Lower Extremity Functional Scale, and Patient's Global Impression of Change instruments; grip strength; walking speed; quality of life (Patient-Reported Outcomes Measurement Information System Physical Fucntion-10); pain; and analgesic use. RESULTS: Seventy-four patients received study drug (45 FabAV, 29 placebo). Mean age was 43 years (range 12 to 86 years). Fifty-three percent were men, 62% had lower extremity envenomation, and 88% had mild initial severity. The primary outcome, the least square mean Patient-Specific Functional Scale score at 14 days postenvenomation, was 8.6 for FabAV-treated subjects and 7.4 for placebo recipients (difference 1.2; 95% confidence interval 0.1 to 2.3; P=.04). Additional outcome assessments generally favored FabAV. More FabAV-treated subjects experienced treatment-emergent adverse events (56% versus 28%), but few were serious (1 in each group). CONCLUSION: Treatment with FabAV reduces limb disability measured by the Patient-Specific Functional Scale 14 days after copperhead envenomation.
RCT Entities:
STUDY OBJECTIVE:Copperhead snake (Agkistrodon contortrix) envenomation causes limb injury resulting in pain and disability. It is not known whether antivenom administration improves limb function. We determine whether administration of antivenom improves recovery from limb injury in patients envenomated by copperhead snakes. METHODS: From August 2013 through November 2015, we performed a multicenter, randomized, double-blind, placebo-controlled, clinical trial to evaluate the effect of ovine Crotalidae polyvalent immune Fab (ovine) (CroFab; FabAV) antivenom therapy on recovery of limb function in patients with copperhead snake envenomation at 14 days postenvenomation. The study setting was 18 emergency departments in regions of the United States where copperhead snakes are endemic. Consecutive patients aged 12 years or older with mild- to moderate-severity envenomation received either FabAV or placebo. The primary outcome was limb function 14 days after envenomation, measured by the Patient-Specific Functional Scale. Additional outcomes included the Patient-Specific Functional Scale at other points; the Disorders of the Arm, Shoulder, and Hand, Lower Extremity Functional Scale, and Patient's Global Impression of Change instruments; grip strength; walking speed; quality of life (Patient-Reported Outcomes Measurement Information System Physical Fucntion-10); pain; and analgesic use. RESULTS: Seventy-four patients received study drug (45 FabAV, 29 placebo). Mean age was 43 years (range 12 to 86 years). Fifty-three percent were men, 62% had lower extremity envenomation, and 88% had mild initial severity. The primary outcome, the least square mean Patient-Specific Functional Scale score at 14 days postenvenomation, was 8.6 for FabAV-treated subjects and 7.4 for placebo recipients (difference 1.2; 95% confidence interval 0.1 to 2.3; P=.04). Additional outcome assessments generally favored FabAV. More FabAV-treated subjects experienced treatment-emergent adverse events (56% versus 28%), but few were serious (1 in each group). CONCLUSION: Treatment with FabAV reduces limb disability measured by the Patient-Specific Functional Scale 14 days after copperhead envenomation.
Authors: Eric J Lavonas; Randy I Burnham; John Schwarz; Eugenia Quackenbush; Brandon Lewis; S Rutherfoord Rose; Spencer Greene; Eric A Toschlog; Nathan P Charlton; Michael E Mullins; Richard Schwartz; David Denning; Kapil Sharma; Kurt Kleinschmidt; Sean P Bush; Victoria E Anderson; Adit A Ginde; Charles J Gerardo Journal: J Med Toxicol Date: 2019-09-03
Authors: Caroline E Freiermuth; Eric J Lavonas; Victoria E Anderson; Kurt C Kleinschmidt; Kapil Sharma; Malin Rapp-Olsson; Charles Gerardo Journal: West J Emerg Med Date: 2019-04-26
Authors: Charles J Gerardo; Joao R N Vissoci; Leonardo P de Oliveira; Victoria E Anderson; Eugenia Quackenbush; Brandon Lewis; S Rutherfoord Rose; Spencer Greene; Eric A Toschlog; Nathan P Charlton; Michael E Mullins; Richard Schwartz; David Denning; Kapil Sharma; Kurt Kleinschmidt; Sean P Bush; Nicklaus P Brandehoff; Eric J Lavonas Journal: PLoS One Date: 2019-03-05 Impact factor: 3.240
Authors: Carsten Lott; Anatolij Truhlář; Anette Alfonzo; Alessandro Barelli; Violeta González-Salvado; Jochen Hinkelbein; Jerry P Nolan; Peter Paal; Gavin D Perkins; Karl-Christian Thies; Joyce Yeung; David A Zideman; Jasmeet Soar Journal: Notf Rett Med Date: 2021-06-10 Impact factor: 0.826
Authors: Andrew M Durso; Rafael Ruiz de Castañeda; Camille Montalcini; M Rosa Mondardini; Jose L Fernandez-Marques; François Grey; Martin M Müller; Peter Uetz; Benjamin M Marshall; Russell J Gray; Christopher E Smith; Donald Becker; Michael Pingleton; Jose Louies; Arthur D Abegg; Jeannot Akuboy; Gabriel Alcoba; Jennifer C Daltry; Omar M Entiauspe-Neto; Paul Freed; Marco Antonio de Freitas; Xavier Glaudas; Song Huang; Tianqi Huang; Yatin Kalki; Yosuke Kojima; Anne Laudisoit; Kul Prasad Limbu; José G Martínez-Fonseca; Konrad Mebert; Mark-Oliver Rödel; Sara Ruane; Manuel Ruedi; Andreas Schmitz; Sarah A Tatum; Frank Tillack; Avinash Visvanathan; Wolfgang Wüster; Isabelle Bolon Journal: Toxicon X Date: 2021-06-22
Authors: Rebecca G Theophanous; Joao Ricardo Nickenig Vissoci; Fan Hui Wen; S Michelle Griffin; Victoria E Anderson; Michael E Mullins; Nicklaus P Brandehoff; Eugenia B Quackenbush; Sean P Bush; Eric A Toschlog; Spencer C Greene; Kapil Sharma; Kurt Kleinschmidt; Nathan P Charlton; S Rutherfoord Rose; Richard Schwartz; Brandon Lewis; Eric J Lavonas; Charles J Gerardo Journal: PLoS Negl Trop Dis Date: 2019-12-13