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A Randomized, Double-Blind, Placebo-Controlled Study Comparing CroFab® Versus Placebo With Rescue Treatment for Copperhead Snake Envenomation

2014-10-16 19:33:21 | BioPortfolio

Summary

This study will evaluate the recovery from copperhead snake bite in patients with mild or moderate venom effect. Potential subjects will receive CroFab antivenom or placebo. The trial is conducted by emergency room doctors, toxicologists, or surgeons at hospitals in regions where copperhead bites are common. After blinded treatment and discharge, the subject returns to the clinic for follow-up assessments at day 3, 7, 14, and 28 after snake bite. The subject will also be called by telephone for follow-up assessments on day 10, 17, and 24 after snake bite. The purpose of this study is to compare recovery in copperhead snake bite patients treated with antivenom versus placebo (no active drug) as measured by the Patient Specific Functional Scale (PSFS) at Day 14 follow-up.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Agkistrodon Contortrix Envenomation

Intervention

crotilidae polyvalent immune fab (ovine), Placebo

Location

Georgia Regents University
Augusta
Georgia
United States
30912

Status

Recruiting

Source

BTG International Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-10-16T19:33:21-0400

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Medical and Biotech [MESH] Definitions

A genus of venomous snakes of the subfamily Crotalinae. Twelve species of this genus are found in North and Central America and Asia. Agkistrodon contortrix is the copperhead, A. piscivorus, the cottonmouth. The former is named for its russet or orange-brown color, the latter for the white interior of its mouth. (Goin, Goin, and Zug, Introduction to Herpetology, 3d ed, p336; Moore, Poisonous Snakes of the World, 1980, p75)

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