NCT00639951

Study to Evaluate the Efficacy of Two Treatment Schemes With Antivipmyn ® for the Treatment of Snake Bite Envenomation

Multicentric, Randomized,Controlled and Comparative Study to Evaluate the Efficacy of Two Treatment Schemes With Antivipmyn ® for the Treatment of Snake Bite Envenomation

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Instituto Bioclon S.A. de C.V. · Industry
• Sex: All
• Age: 6 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare whether a same total dose given up front as a single dose is more effective and as safe as the same dose given as a fractioned dose. Evaluate the Utility of the the Dry Tube Test Evaluating its Correlation with Coagulation Test Results (fibrinogen, platelets, INR, PT and PTT). Explore the Evolution of some Serum Markers (CK, DHL, metalloproteinase), Amount of Venom and Antivenom Levels and the Progression of Local Lesions.

Detailed description

Snake bite Envenomation is a Public Health Problem especially for tropical and subtropical countries. The WHO estimates 40 000 annual deaths in the world for this cause. In México the Ministry of Health estimated 3 882 cases on 2005, being the age of 15-44 the most affected. There are not official numbers of mortality, although the thought is that there are few cases of death, most of them related with a delay on treatment. There are a broad variety of clinical presentations depending on many factors such as species, snake bite variability or patient conditions. Proteolytic action of venom produces amines and vasoactive peptides such as bradykinin, histamine and serotonin which cause capillary lesions with anticoagulant effects. Coagulopathy is one of the most important systemic consequences. The Dry Tube Test has been proposed as an indirect test to evaluate coagulopathy related to this pathology.

Conditions

• Snake Bite

Interventions

Type	Name	Description
BIOLOGICAL	A	20 vials up front in a Single Dose of Antivipmyn
BIOLOGICAL	Antivipmyn ®	20 vials fractionated into 4 doses of 5 vials each of Antivipmyn ®

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-01-01
• Completion: 2009-03-01
• First posted: 2008-03-20
• Last updated: 2016-07-20

Locations

5 sites across 1 country: Mexico