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

Snake Bite Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00639951
• Other study ID #: YA-07/01
• Status: Terminated
• Phase: Phase 4
• First received: March 13, 2008
• Last updated: July 18, 2016
• Start date: January 2008
• Est. completion date: March 2009

Study information

• Verified date: July 2016
• Source: Instituto Bioclon S.A. de C.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of HealthMexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 65 Years

Eligibility

Inclusion Criteria:

• Men and women 6 to 65 years of age

• Presenting for emergency treatment of snake bite

• Requiring treatment with antivenom

• Informed consent document read and signed by patient (or parent/legal guardian)

• Participation within the last month on any clinical trial

• Arrival to Hospital within 24 hours after the snake bite

Exclusion Criteria:

• Allergy to horse serum

• Underlying medical conditions that significantly alter coagulation (oral anticoagulants, vitamin K deficiency, hepatic disease)

• Use of AINE 48 hours previously

• Use of any antivenom 2 weeks previously

• Pregnancy or breast-feeding women

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Snake Bite
• Snake Bites

Intervention

Biological:
• A
20 vials up front in a Single Dose of Antivipmyn
• Antivipmyn ®
20 vials fractionated into 4 doses of 5 vials each of Antivipmyn ®

Locations

Country	Name	City	State
Mexico	Ciudad Valles Site	Ciudad Valles	San Luis Potosi
Mexico	Hospital Universitario de la UANL "Dr. José Eleuterio González"	Monterrey	NL
Mexico	Hermosillo Site	Sonora	Hermosillo
Mexico	Tempoal Site	Tempoal	Veracruz
Mexico	Nayarit Site	Tepic	Nayarit

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Bioclon S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of systemic signs and symptoms of snake bite envenomation expressed as % of patients requiring additional antivenom and % of patients that are stable		12 hours after initial treatment	No
Secondary	Evaluate the correlation between Dry Tube Test and Coagulation Test (PT, INR, PTT, platelets and fibrinogen)		baseline, 2,4,6 hours and after each extra dose of Antivenom	No
Secondary	Evaluate Venom and Antivenom Levels with the other parameters		baseline, 2 hours after initial treatment and after each extra dose of Antivenom	Yes
Secondary	Evaluate the possible relation of the serum markers (LDH, CPK, metalloproteinases)and local damage evolution.		baseline, 2, 4,6 and after each extra dose of Antivenom	No