Non-inferiority Trial of Two Snake Antivenoms in CAR (PAVES)

Launched by EPICENTRE · Feb 24, 2016

Keywords

ClinConnect Summary

The study is designed as a randomized, double-blind, non-inferiority trial among patients suffering envenoming following snakebite in Paoua, Central African Republic. The primary aim of the study is to assess the non-inferiority of EchiTabPlus-ICP compared to FAV-Africa, at preventing a composite primary endpoint consisting of death from any cause, need for blood transfusion or need for a third dose of antivenom.

A total of 196 patients will be individually randomized in a 1:1 ratio to receive FAV-Africa or EchiTabPlus-ICP.

The first dose of intervention antivenom will be administered at ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • present within 72 hours of snakebite
• • have signs and symptoms of grade 2 envenoming (oedema beyond the elbows or knees, bleeding at site of bite, bleeding from the gums or hematuria) or grade 3 envenoming (oedema to the shoulders or hips, or serious bleeding - epistaxis, hemoptysis, gastrointestinal bleeding)
• • lack of coagulation of blood at 20 minutes in a dry vacutainer tube (abnormal 20 minute WBCT)
• Exclusion Criteria:
• • known allergy to horses or heterologous proteins of equine origins
• • pregnancy
• • have received antivenom since the snakebite